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RRC APPLICATION FORM
RESEARCH PROTOCOL NUMBER: 2009-002
FOR OFFICE USE ONLY
RRC Approval: Yes / No Date: ERC Approval: Yes / No Date: AEEC Approval: Yes / No Date:
Protocol Title: A study on selected micronutrient intake of 2-4 years old children into lower socio economic status (SES).
Short title (in 50 characters including space): Present micronutrients status of 2-4 years old children.
Theme: (Check all that apply)
Nutrition Emerging and Re-emerging Infectious Diseases Population Dynamics Reproductive Health Vaccine Evaluation HIV/AIDS
Environmental Health Health Services Child Health Clinical Case Management Social and Behavioural Sciences
Key words: Micronutrients, Micronutrient deficiency, Micronutrient deficiency related diseases.Relevance of the Protocol:We anticipate that the findings of this study will help identify the present micronutrients(selected) intake level of 2-4 years old children into lower socio economic status (SES).Centre’s Priority (as per Strategic Plan, to be imported from the attached Separate Word Sheet):3.4 Improving micronutrient nutrition through evaluating the present selected micronutrient intake of the children aged 2-4 years old onto lower socio economic status (SES).Programmes:
Child Health Programme Nutrition Programme Programme on Infectious Diseases & Vaccine Science Poverty and Health Programme
Health and Family Planning Systems Programme Population Programme Reproductive Health Programme HIV/AIDS Programme
Principal Investigator (Should be a Centre’s staff)
Dr. S.K. RoyAddress (including e-mail address): Senior, Scientist, ICDDR,B, Mohakhali, Dhaka 1212; Phone: 8860523 (Extn. 2313); Email: [email protected]
DIVISION:
CSD LSD HSID PHSD
Co-Principal Investigator(s): Internal Co-Principal Investigator(s): External: (Please provide full official address including e-mail address and Gender) Co-Investigator(s): Internal:
Co-Investigator(s): External (Please provide full official address including e-mail address and GenderDr. Sufia Islum, Associate Professor,Department of Pharmacy,East West University,43,C/A,Mohakhali,Dhaka-1212.Phone:01914282327.Student Investigator(s): Internal (Centre’s staff):
1
Student Investigator(s): External:(Please provide full address of educational institution and Gender) 1. Cynthia Ummay Siddiqua
East West University,43,C/A,Mohakhali,Dhaka-1212.Mobile-01913101530.
2. Abida Sultana LizaEast West University,43,C/A,Mohakhali,Dhaka-1212.
Mobile-019236110553. Shovon Kumar Das
East West University,43,C/A,Mohakhali,Dhaka-1212. Mobile-01911669166
Collaborating Institute(s): Please Provide full address
Institution # 1
Institution # 2
2
Country Bangladesh
Contact person Dr. Sufia Islum
Department(including Division, Centre, Unit) Pharmacy
Institution(with official address)
East West University, 43, C/A, Mohakhali,Dhaka-1212.
Directorate(in case of GoB i.e. DGHS)
Ministry (in case of GoB)
Country
Contact person
Department(including Division, Centre, Unit)
Institution(with official address)
Directorate(in case of GoB i.e. DGHS)
Ministry (in case of GoB)
Institution # 3
Country
Contact person
Department(including Division, Centre, Unit)
Institution(with official address)
Directorate(in case of GoB i.e. DGHS)
Ministry (in case of GoB)
Note: If more than 3 collaborating institutions are involved in the research protocol, additional block(s) can be inserted to mention its/there particular(s).
Population: Inclusion of special groups (Check all that apply):
Sex Male Female
Age 0 – 4 years 5 – 9 years 10 – 19 years 20 – 64 years 65 +
Pregnant Women Fetuses Prisoners Destitutes Service Providers Cognitively Impaired CSW Others (specify ) Animal
NOTE It is the policy of the Centre to include men, women, and children in all research projects involving human subjects unless a clear and compelling rationale and justification (e.g. gender specific or inappropriate with respect to the purpose of the research) is there. Justification should be provided in the `Sample Size’ section of the protocol in case inclusiveness of study participants is not proposed in the study.
Project/study Site (Check all the apply):
Dhaka Hospital Matlab Hospital Matlab DSS Area Matlab non-DSS Area Mirzapur
Dhaka Community(Different Muhallas of Mirpur,Mohakhali and Mughda thana)
Chakaria Abhoynagar
Mirsarai Patyia Other areas in Bangladesh Outside Bangladesh
Name of Country: Multi Centre Trial
(Name other countries involved):
3
Type of Study (Check all that apply):
Case Control Study Community-based Trial/Intervention Program Project (Umbrella) Secondary Data Analysis Clinical Trial (Hospital/Clinic) Family Follow-up Study
Cross Sectional Survey Longitudinal Study (cohort or follow-up) Record Review Prophylactic Trial Surveillance/Monitoring Others:
NOTE: Does the study meet the definition of clinical studies/trials given by the International Committee of Medical Journal Editors (ICMJE)? Yes No
Please note that the ICMJE defined clinical trial as “Any research project that prospectively assigns human
subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome”.
If YES, after approval of the ERC, the PI should complete and send the relevant form to provide required
information about the research protocol to the Committee Coordination Secretariat for registration of the study into websites, preferably at the www.clinicaltrials.gov. It may please be noted that the PI would require to provide subsequent updates of the research protocol for updating protocol information in the website.
Targeted Population (Check all that apply):
No ethnic selection (Bangladeshi) Bangalee Tribal group
Expatriates Immigrants Refugee
Consent Process (Check all that apply):
Written Oral None
Bengali Language English Language
Proposed Sample Size:Sub-group (Name of subgroup (e.g. Men, Women) and Number
Name Number Name Number
(1) Micronutrients intake level into 2-4 years old children.
189 (3)
(2) (4) Total sample size: 189Determination of Risk: Does the Research Involve (Check all that apply):
Human exposure to radioactive agents? Fetal tissue or abort us? Investigational new device?
(specify: ) Existing data available from Co-investigator
Human exposure to infectious agents? Investigational new drug Existing data available via public archives/sources Pathological or diagnostic clinical specimen only Observation of public behaviour
New treatment regime
4
Could the information recorded about the individual if it became known outside of the research:
Do you consider this research (Check one):
Greater than minimal risk No more than minimal risk Only part of the diagnostic test
Minimal Risk is "a risk where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical, psychological examinations or tests. For example, risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as a part of routine physical examination".
Yes/ No
Is the proposal funded?
If yes, sponsor Name: (1) (2)
Yes/No
Is the proposal being submitted for funding?
If yes, name of funding agency: (1)
(2)
Do any of the participating investigators and/or member(s) of their immediate families have an equity relationship (e.g. stockholder) with the sponsor of the project or manufacturer and/or owner of the test product or device to be studied or serve as a consultant to any of the above?
IF YES, a written statement of disclosure to be submitted to the Centre’s Executive Director.
Dates of Proposed Period of Support Cost Required for the Budget Period ($)
(Day, Month, Year - DD/MM/YY) Beginning Date : As soon as approved End Date : 6 month from starting
5
Yes No Is the information recorded in such a manner that study participants can be identified from information provided directly or through identifiers linked to the study participants?
Yes No Does the research deal with sensitive aspects of the study participants’ behaviour; sexual behaviour, alcohol use or illegal conduct such as drug use?
Yes No Place the study participants at risk of criminal or civil liability?
Yes No Damage the study participants’ financial standing, reputation or employability, social rejection, lead to stigma, divorce etc.?
Years Direct CostIndirect
CostTotal Cost
Year-1 300$ 0Year-2 0Year-3 0Year-4 0Year-5 0Total 0 0 300 $
Certification by the Principal InvestigatorI certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept the responsibility for the scientific conduct of the project and to provide the required progress reports including updating protocol information in the SUCHONA (Form # 2) if a grant is awarded as a result of this application.
___________ ____________Signature of PI Date Approval of the Project by the Division Director of the Applicant
The above-mentioned project has been discussed and reviewed at the Division level as well by the external reviewers. The protocol has been revised according to the reviewers’ comments and is approved.
Name of the Division Director Signature Date of Approval
6
Table of Contents
RRC APPLICATION FORM...................................................................................................................1Project Summary......................................................................................................................................4Description of the Research Project.........................................................................................................4
Hypothesis to be Tested:.......................................................................................................................4Specific Aims:......................................................................................................................................4Background of the Project including Preliminary Observations..........................................................4Research Design and Methods.............................................................................................................4Sample Size Calculation and Outcome Variable(s).............................................................................4Facilities Available...............................................................................................................................4Data Safety Monitoring Plan (DSMP)..................................................................................................4Data Analysis........................................................................................................................................4Ethical Assurance for Protection of Human Rights..............................................................................4Use of Animals.....................................................................................................................................4Literature Cited.....................................................................................................................................4Dissemination and Use of Findings......................................................................................................4Collaborative Arrangements.................................................................................................................4
Biography of the Investigators.................................................................................................................4Biography of the Investigators.................................................................................................................4Biography of the Investigators.................................................................................................................4Budget Justifications.................................................................................................................................4Other Support...........................................................................................................................................4Check-List................................................................................................................................................4
Check here if appendix is included
7
Project SummaryDescribe in concise terms, the hypothesis, objectives, and the relevant background of the project. Also describe concisely the experimental design and research methods for achieving the objectives. This description will serve as a succinct and precise and accurate description of the proposed research is required. This summary must be understandable and interpretable when removed from the main application.
Principal Investigator(s): Dr. S.K. RoyResearch Protocol Title: A study on selected micronutrient intake of 2-4 years old children into lower socio economic status (SES).
Total Budget US$: 294 $ Beginning Date :As soon as approved Ending Date: 6 months from beginningMicronutrients are of much importance in social and individual health. Micronutrients include variants
vitamins and minerals such as vitamin A vitamin D, iron, Zinc and selenium . Because if our daily diet
do not contain adequate amount of these necessary micronutrients then there will be various types of
health problems such as night blindness, anaemia, rickets etc.Young children, women of childbearing
age, those recovering from an illness are most at risk of developing micronutrients deficicecies.
Micronutrient deficiencies are so important to public health outcomes, particularly in the developing
countries like Bangladesh. Lack of knowledge about the dietary intake ,caring practices for the
children ,less opportunity for disease control etc. are the main reasons of micronutrient deficiency
specially in children/ infant of Bangladesh .The hypothesis of our project is to focus on the selected
micronutrients intake of 2-4 years old children into lower socio-economic status (SES). Selected
micronutrients intake information in 2-4 years old children into lower socio economic status (SES)
should be collected from the children’s mother or other family members and followed by the 24 hour
dietary recall method .The collecting data including both the qualitative and quantitative data should
be analyzed to achieve the research objectives. The main objective of this research is to find out the
present selected micronutrients intake level of that particular aged group of children and compared
the present status with the standard /(RDA) . As the result of this comparison we can find out that the
micronutrients intake in 2-4 years old children is satisfying their daily requirement or not. The results
will be analyzed to determine the present selected micronutrient status into 2-4 years old children of
the lower socio-economic status with the standard daily requirement of the selected micronutrient.
KEY PERSONNEL (List names of all investigators including PI and their respective specialties)
Name Professional Discipline/ Specialty Role in the Project1. Dr. S. K. Roy Scientist ICDDR,B,CSD Principal supervisor
2. Cynthia Ummay Undergraduate student Investigator
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Siddiqua
3. Abida Sultana Liza Undergraduate student Investigator
4. Shovon Kumar Das Undergraduate student Investigator
5.
6.
7.
8.
9.
10.
Description of the Research ProjectHypothesis to be Tested:
Concisely list in order, the hypothesis to be tested and the Specific Aims of the proposed study. Provide the scientific basis of the hypothesis, critically examining the observations leading to the formulation of the hypothesis.
We hypothesize that the present micronutrient (selected) intake of 2-4 years old children into lower socio economic status (SES) is 40% less than the recommended dietary allowance (RDA).Specific Aims:
Describe the specific aims of the proposed study. State the specific parameters, biological functions/ rates/ processes that will be assessed by specific methods.
OBJECTIVES:General Objective:To determine the selected micronutrients intake level of 2-4 years old children into lower socio economic status (SES).
Specific objectives:
1. To find the present selected micronutrient intake of 2-4 years old children.
2. To find the 24 hour food intake of that particular aged children group.
3. To find the socio-economic status and profession of the parents.
4. To find the level of family care of the children in health issues to determine their daily dietary food
intake.
9
Background of the Project including Preliminary Observations
Describe the relevant background of the proposed study. Discuss the previous related works on the subject by citing specific references. Describe logically how the present hypothesis is supported by the relevant background observations including any preliminary results that may be available. Critically analyze available knowledge in the field of the proposed study and discuss the questions and gaps in the knowledge that need to be fulfilled to achieve the proposed goals. Provide scientific validity of the hypothesis on the basis of background information. If there is no sufficient information on the subject, indicate the need to develop new knowledge. Also include the significance and rationale of the proposed work by specifically discussing how these accomplishments will bring benefit to human health in relation to biomedical, social, and environmental perspectives.
MicronutrientsThey are called micronutrients because they are needed only in small amounts (<100mg/day), these
substances are the “magic wands” that enable the body to produce enzymes, hormones and other
substances essential for proper growth and development. As tiny as the amounts are, however, the
consequences of their absence are severe. Iodine, vitamin A and iron are most important in global public
health terms; their lack represents a major threat to the health and development of populations the world
over, particularly children and pregnant women in low-income countries including Bangladesh [1]. Foods
contain micronutrients that provide benefits via more subtle interactions with the body's chemistry.
Micronutrients are active and potent in relatively tiny quantities, measured in milligrams or even
micrograms [2]. Gererally Micronutrients are vitamins and minerals that boost the nutritional value of
food [3].
Vitamins:
The first micronutrients that scientists studied were vitamins: A (retinenes), B complex (thiamine, niacin,
pyridoxine, folic acid, pantothenic acid, and B12), C (ascorbic acid), D, and K [2].Vitamin A,D,E,K are
fat soluble and vitamin B and C are water soluble.Although there are still debates as to optimal doses of
these vitamins for various age groups and for men versus women, there is no question that these
compounds are essential components of a healthy diet.[2]
Minerals:
We know a great about why we need minerals and how they work. We need calcium (a major
component of bone) and iron (needed for hemoglobin in blood) in relatively large quantities.Iodine is
needed in modest amounts to make thyroid hormone .We require other minerals such as zinc,
magnesium, and cobalt, in much smaller quantities, but they are still essential, mainly as enzyme
components. A healthy diet with a reasonable balance of meat, leafy vegetables, and fruit generally
supplies the trace elements we need and many people also take mineral supplements, often in
combination with vitamins [2].
Role of Micronutrients in health:Micronutrients are vitamins and minerals that all humans need to maintain strong bodies and mental
sharpness, fight off disease, and bear healthy children .Micronutrient deficiency is caused by inadequate
access to micronutrient-rich food, high burden of infection and parasites, and detrimental feeding and 10
dietary practices. Micronutrient deficiency adversely affects the health and function of individuals and
the economic and social development of communities and nations .Vitamin A, iron, iodine, zinc, and
folate among others profoundly affect child survival, women’s health, educational achievement, adult
productivity, and overall resistance to illness.[3]The role of certain micronutrients on the human health
are given below:
Vitamin AVitamin A is essential for optimal health, growth, and development .Vitamin A deficiency is a major
underlying determinant of child mortality and blindness in the developing world. It causes
xerophthalmia , a serious eye disorder that can lead to blindness if untreated.In children, vitamin A
deficiency compromises the immune system, increasing the risk of severe illness and death from diarrheal
diseases and other infections, such as measles[3].
IronIron is essential for good health and mental and physical well-being. Iron deficiency anemia occurs when
the body's iron supply cannot support the production of hemoglobin in adequate amounts to carry enough
oxygen from the lungs to the muscles, brain, and other tissues. This causes weakness, fatigue, and
reduced physical ability to work. Iron deficiency in children slows intellectual and motor development.
The main causes of iron deficiency are low consumption of meat, fish, or poultry or the presence of
inhibitors in the diet that prevent iron from being absorbed. In resource-poor areas, anemia is commonly
caused by infectious diseases such as malaria, hookworm, and HIV/AIDS [3].
Zinc
Zinc is an essential element that promotes healthy immune system functioning and protects against
infectious diseases. Adequate zinc nutrition is necessary for optimal child health and survival, physical
growth, and for a normal pregnancy. Zinc deficiency in children results in increased risk of diarrhea,
pneumonia, and malaria. Zinc is important in the treatment of diarrhea in children. Limited access to
zinc-rich foods, such as animal products and shellfish, and inadequate absorption of zinc cause zinc
deficiency [3].
Micronutrients Deficiency:
When a daily diet does not contain adequate levels of micronutrients, the outcome can have dramatic
consequences: children do not reach their full intellectual capacity, growth can be stunted, and even
blindness can occur. In the worst case, a lack of essential nutrients can result in death. More than two
billion people worldwide lack minute quantities of essential nutrients to keep them healthy.
Unfortunately, the poor—especially women and children in developing countries—are the most
vulnerable. For example, from data supplied by the Micronutrient Initiative:
11
2 million children may die unnecessarily each year because they lack vitamin A, zinc, or other
nutrients.
19 million infants are born with impaired mental capacity every year due to iodine deficiency.
100,000 babies are born each year with preventable physical defects .Iron deficiency undermines
the health and energy of 40 percent of women in the developing world. Severe anemia kills more
than 60,000 women each year, especially during childbirth.
Vitamin and mineral deficiencies account for 10 percent of the global health burden [3].
Table: 01
Micronutrient Deficiency diseases
Anaemia Anaemia can be caused by lack of iron, folate or vitamin B12. It is difficult to
diagnose accurately from clinical signs which include pallor, tiredness, 12
headaches and breathlessness.
Beri-beri Beri-beri is caused by thiamin deficiency. There are many clinically
recognisable syndromes including wet beri-beri, dry beri-beri and infantile beri-
beri.
Bitot's spots Dryness accompanied by foamy accumulations on the conjunctiva, that often
appear near the outer edge of the iris, and caused by vitamin A deficiency.
Cretinism Severe mental and physical disability which occurs in the offspring of women
with severe iodine deficiency in the first trimester of pregnancy.
Goitre Swelling of the thyroid gland in the neck caused by iodine deficiency.
Iodine Deficiency Disorders (IDD)
IDDs cover a range of abnormalities including goitre and cretinism.
Night blindness Inability to see well in the dark or in a darkened room. An early sign of vitamin
A deficiency.
Pellagra Pellagra is caused by niacin deficiency which affects the skin, gastro-intestinal
tract and nervous systems and is sometimes called the 3Ds: dermatitis, diarrhoea
and dementia.
Rickets Rickets is caused by calcium deficiency and adversely affects bone development
resulting in bowing of the legs when severe.
Scurvy Scurvy is caused by Vitamin C deficiency. Typical signs include swollen and
bleeding gums, and slow healing or re-opening of old wounds.
Xerophthalmia Xerophtalmia is caused by Vitamin A deficiency and refers to a range of eye
signs including night blindness, Bitot's spots and corneal ulceration.
(4)
Nutrition situation in Bangladesh Dietary pattern
Cereals, largely rice, are the main food in Bangladesh. Nearly two-thirds of the daily diet consists of rice,
some vegetables, a little amount of pulses and small quantities of fish if and when available. Milk, milk
products and meat are consumed only occasionally and in very small amounts. Fruit consumption is
seasonal and includes mainly papaya and banana which are cultivated round the year. The dietary intake
of cooking oil and fat is meager. The typical rural diet in Bangladesh is, reportedly, not well balanced
13
[5].While food habits vary at regional and even individual household levels, in general, food preparation
methods result in significant nutrient loss. Minerals and vitamins, especially B-complex vitamins are lost
(40 percent of thiamine and niacin) even during the washing of rice before cooking. Boiling rice and then
discarding the water results in even more nutrient losses. Household food consumption studies [6] show
that cereals make up the largest share (62 percent) of the diet, followed by non-leafy vegetables, roots and
tubers, which together comprise more than four-fifths of the rural people’s total diet. Rural consumption
of leafy and non-leafy vegetables has remained more or less the same over the past two decades after
increasing over the preceding 30 years. Fruit consumption has declined in rural areas after more than
doubling in the 1970s. With an average national per capita consumption of 23 g of leafy vegetables, 89 g
of non-leafy vegetables and 14 g of fruit, the average Bangladeshi eats a total of 126 g of fruit and
vegetables daily. This is far below the minimum daily consumption of 400 g of vegetables and fruit
recommended by FAO and the World Health Organization (WHO) [7].
Nutritional statusNutritional status: Data from BDHS 2004 show that 43% of Bangladeshi children under-five are short
for their age or stunted, while 17% are severely stunted. The prevalence of stunting increases with
age from 10% of children under six months of age, to 51% of children aged 48-59 months. Additionally,
13% of the Bangladeshi children are seriously underweight for their height, or wasted, and 1% are
severely wasted. The wasting peaks at age of 12-23 months with around 24% of under-fives in that age
group diagnosed as suffering from wasting. The proportion of young child with wasting decreases after
23 months of age, and is 10% for children aged 48-59 months. Forty eight per cent of children are
considered under weight (low weight for age), and 13% are classified as severely underweight (BDHS
2004).
The underlying causes include the common reasons of micronutrients deficiency in Bangladesh:
(i) household food insecurity resulting from inability to grow or purchase a nutritionally adequate
amount and variety of food;
(ii) lack of dietary diversity;
(iii) inadequate maternal and child care due to inappropriate hygiene, health and nutrition;
(iv) low rates of exclusive breast feeding;
14
(v) inadequate access to quality health services;
(vi) Poor environmental hygiene and sanitation along with low levels of income and maternal
formal education. Malnutrition early in life has long-lasting and negative effects on overall
growth, morbidity, cognitive development, educational attainment and adult productivity [8].
Because of this, the nutritional status of children, particularly below five years of age, is seen as one of
the most sensitive indicators of a country’s vulnerability to food insecurity and overall socio-economic
development. Therefore in this research we should focus on all the above reasons and on that basis we
will try to find out the micronutrients (selected) level into children aged 2-4 years old into lower socio
economic status (SES).
Nutrition triangle :
UNICEF nutrition triangle strategy defines the necessary ingredients to promote good nutrition as – food
security, care of women and children and disease control.
Food security
Disease control Caring practice
Nutritional status of infant and young children is closely related with food security, disease control and
caring practices. Most form of malnutrition result from a combination of causes that include inadequate
dietary intake and frequent illnesses. Major causes include not having access to enough nutritious foods;
inadequate health services and poor environmental sanitation and inappropriate caring and feeding
practices (9).
Selection of Micronutrients:
There are a large number of micronutrients which means vitamins and minerals present in our dietary
foods. Therefore in our research we emphasize to determine only a few of the selected micronutrients that
are taken by the 2-4 years old children into different socio economic status (SES). The selected
micronutrients are:
15
Vitamin A
Iron
Zinc
Description of the above three micronutrients and their deficiency disorders, Recommended Dietary Allowance (RDA) and present situation in Bangladesh are given below: Vitamin AVitamin A is essential for optimal health, growth, and development .Vitamin A deficiency is a major
underlying determinant of child mortality and blindness in the developing world. It causes
xerophthalmia , a serious eye disorder that can lead to blindness if untreated. In children, vitamin A
deficiency compromises the immune system, increasing the risk of severe illness and death from diarrheal
diseases and other infections, such as measles [3].
IronIron is essential for good health and mental and physical well-being. Iron deficiency anemia occurs when
the body's iron supply cannot support the production of hemoglobin in adequate amounts to carry enough
oxygen from the lungs to the muscles, brain, and other tissues. This causes weakness, fatigue, and
reduced physical ability to work. Iron deficiency in children slows intellectual and motor development.
The main causes of iron deficiency are low consumption of meat, fish, or poultry or the presence of
inhibitors in the diet that prevent iron from being absorbed. In resource-poor areas, anemia is commonly
caused by infectious diseases such as malaria, hookworm, and HIV/AIDS [3].
Zinc
Zinc is an essential element that promotes healthy immune system functioning and protects against
infectious diseases. Adequate zinc nutrition is necessary for optimal child health and survival, physical
growth, and for a normal pregnancy. Zinc deficiency in children results in increased risk of diarrhea,
pneumonia, and malaria. Zinc is important in the treatment of diarrhea in children. Limited access to
zinc-rich foods, such as animal products and shellfish, and inadequate absorption of zinc cause zinc
deficiency [3].
The Recommended Dietary Allowance (RDA) of Vitamin A
The RDA for vitamin A was revised by the Food and Nutrition Board (FNB) of the Institute of Medicine
in 2001. The latest RDA is based on the amount needed to ensure adequate stores (four months) of
vitamin A in the body to support normal reproductive function, immune function, gene expression, and
vision [10]. The table below lists the RDA values in both micrograms (mcg) of Retinol Activity
Equivalents (RAE) and international units (IU).
Table 02: Recommended Dietary Allowance for Vitamin A
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Recommended Dietary Allowance (RDA) for Vitamin A as Preformed Vitamin A (Retinol Activity Equivalents)
Life Stage Age Males: mcg/day (IU/day) Females: mcg/day (IU/day)
Infants (AI) 0-6 months 400 (1,333 IU) 400 (1,333 IU)
Children 1-3 years 300 (1,000 IU) 300 (1,000 IU)
Children 4-8 years 400 (1,333 IU) 400 (1,333 IU)
In this research we will compare this standared amount of vitamin A with the normal food intake level
into children aged 2-4 years old by considering their daily food sources or daily food habitation using 24
hour dietary re-call method.
Vitamin A deficiency in Bangladesh:
Vitamin A deficiency (VAD) is a public health problem around the world, with the highest number of
clinical cases occurring in South-East Asia1. VAD has been found to be associated with increased
morbidity and mortality among pre-school children and evidence now confirms that improving the
vitamin A status of deficient children can increase their chance of survival by over 23%[11]. VAD is also
known to influence the growth of children and precipitates anaemia [12-15].In Bangladesh, VAD has
been recognized as a public health problem for more than a decade[39]. However, most vitamin A
research has focused on infants and children. More than 85% of Bangladeshi infants continue to be
breast-fed through the first year of life and some continue partial breast-feeding until more than 2 years of
age[16,17].Infants who are born with low vitamin A stores mostly rely on their mother’s breast milk
vitamin A concentration to meet their needs. The breast milk vitamin A concentration is related to
maternal vitamin A status and has direct implications on infants’ health and survival [18,19,20].
Iron:
One of the most abundant metals on Earth, is essential to most life forms and to normal human
physiology. Iron is an integral part of many proteins and enzymes that maintain good health. In humans,
iron is an essential component of proteins involved in oxygen transport [21,22]. It is also essential for the
regulation of cell growth and differentiation [23,24]. A deficiency of iron limits oxygen delivery to cells,
resulting in fatigue, poor work performance, and decreased immunity [21,25]. On the other hand, excess
amounts of iron can result in toxicity and even death [26]. Almost two-thirds of iron in the body is found
in hemoglobin, the protein in red blood cells that carries oxygen to tissues. Iron is also found in proteins
that store iron for future needs and that transport iron in blood. Iron stores are regulated by intestinal iron
absorption [25,27].
17
Table 03: Recommended Dietary Allowances for Iron for Infants (7 to 12 months), Children, and
Adults [25]
AgeMales
(mg/day)
Females
(mg/day)
Pregnancy
(mg/day)
Lactation
(mg/day)
7 to 12 months 11 11 N/A N/A
1 to 3 years 7 7 N/A N/A
4 to 8 years 10 10 N/A N/A
9 to 13 years 8 8 N/A N/A
14 to 18 years 11 15 27 10
19 to 50 years 8 18 27 9
51+ years 8 8 N/A N/A
Iron deficiency in Bangladesh:
Iron deficiency is a major public health problem, especially in infants, children, and women of
childbearing age in developing countries (28, 29). The consequences of iron deficiency anemia (IDA) are
particularly significant in infants and young children and include abnormalities of immune function, poor
growth, and potentially irreversible deficits of cognition and motor function (29).
Low dietary intake of poorly bioavailable iron is believed to be the principal cause of IDA in the
developing world. Dietary iron in resource-poor areas is predominantly nonheme iron of plant origin,
which contains high amounts of inhibitors of iron absorption, such as phytate (30). Gastric acid secretion
is also an important intraluminal factor for nonheme-iron absorption (31, 32). Ingested dietary ferric (Fe3+)
iron is solubilized and ionized by gastric acid and reduced to the more readily absorbed ferrous (Fe2+)
form. Conditions affecting gastric acid secretion are therefore potentially important factors in the etiology
of IDA (33).
Helicobacter pylori infection is the most common infection worldwide. Its prevalence is very high in
developing countries, such as in Bangladesh, where 60% of children aged <5 y are infected (34).
Infection is typically acquired in childhood and persists throughout life, causing chronic gastritis, a risk
factor for gastric atrophy and gastric cancer (35). Among infected children who have undergone
endoscopy, chronic gastritis is a near universal finding (36,37). An important consequence of chronic H.
pylori gastritis and gastric atrophy is low gastric acid output (38). Low gastric acid secretion results in an
impaired "gastric barrier," which is associated with increased susceptibility to enteric infections, a major
18
public health concern linked to diarrhea, malnutrition, and growth failure in children in the developing
world (39,40). Several reports have indicated an association between H. pylori infection and anemia, iron
deficiency, and IDA, although the nature of the interactions has not been established (41-44).
Zinc:
It is an essential mineral that is naturally present in some foods, added to others, and available as a dietary
supplement. Zinc is also found in many cold lozenges and some over-the-counter drugs sold as cold
remedies.
Table 04: Recommended Dietary Allowances (RDAs) for Zinc [45]
Age Male Female Pregnant Lactating
Birth to 6 months 2 mg* 2 mg*
7 months to 3 years 3 mg 3 mg
4 to 8 years 5 mg 5 mg
9 to 13 years 8 mg 8 mg
14 to 18 years 11 mg 9 mg 13 mg 14 mg
19+ years 11 mg 8 mg 11 mg 12 mg
* Adequate Intake (AI)
Zinc Deficiency
Zinc deficiency is characterized by growth retardation, loss of appetite, and impaired immune function. In
more severe cases, zinc deficiency causes hair loss, diarrhea, delayed sexual maturation, impotence,
hypogonadism in males, and eye and skin lesions [45, 46 ,47,48]. Weight loss, delayed healing of
wounds, taste abnormalities, and mental lethargy can also occur [49, 46, 50-54]. Many of these symptoms
are non-specific and often associated with other health conditions; therefore, a medical examination is
necessary to ascertain whether a zinc deficiency is present.
Table 05: Recommended Dietary Allowances (RDAs) for Zinc [45]
Age Male Female Pregnant Lactating
Birth to 6 months 2 mg* 2 mg*
7 months to 3 years 3 mg 3 mg
4 to 8 years 5 mg 5 mg
9 to 13 years 8 mg 8 mg
19
Rational of the research:
Micronutrient - deficiency is a major health problem in Bangladesh. In Bangladesh, lack of nutritional
and health knowledge is one of the most important causes of high prevalence of Micronutrient –
deficiency especially in the children. Most of the micronutrient deficiency is caused by the combination
of causes that includes inadequate dietary intake, not having access to enough nutritious foods or foods
with lack of required micronutrients, inappropriate caring provided by the family members and feeding
practices and these all factors lead to our assessment of our research . Analyzing all these factors and
there by find out the major reasons which are responsible for adequate or inadequate intake of the
selected micronutrient intake into the children aged 2-4 years of the lower socio economic status (SES).
In our study we want to find the present selected micronutrients intake level of the population Group
(children aged 2-4 years) into the lower Socio Economic Status (SES).Thus we will complete the triple
‘A’ process.
FIGURE : The “Triple A” Process
Conceptual Framework :
From the results and acquired knowledge from this survey, identify the present micronutrients intake
level into 2-4 years old children of the lower socio economic status (SES).
20
Food health, and care are all necessary for healthy survival, growth, and development, according to the
UNICEF conceptual framework (1990). All three elements must be satisfactory for good nutrition. Even
when poverty causes food insecurity and limited health care, enhanced care giving can optimize the use
of existing resources to promote good health and nutrition in women and children. Breastfeeding is an
example of a practice that provides food, health, and care simultaneously.
CARE AND NUTRITION OF YOUNG CHILD
21
Immediate: selected micronutrients deficiency
Underlying: Lack of micronutrient-rich foods in diets; frequent malnutrition and diseases
Basic: lack of nutrition awareness, faulty dietary patterns
Conceptual framework of selected micronutrients intake
Source: UNICEF (1990) Strategy for Improved Nutrition of Children and Women in Developing
Countries. New York: UNICEF.
Research Design and Methods
Describe in detail the methods and procedures that will be used to accomplish the objectives and specific
aims of the project. Discuss the alternative methods that are available and justify the use of the method
proposed in the study. Justify the scientific validity of the methodological approach (biomedical, social,
or environmental) as an investigation tool to achieve the specific aims. Discuss the limitations and
difficulties of the proposed procedures and sufficiently justify the use of them. Discuss the ethical issues
related to biomedical and social research for employing special procedures, such as invasive procedures
in sick children, use of isotopes or any other hazardous materials, or social questionnaires relating to 22
individual privacy. Point out safety procedures to be observed for protection of individuals during any
situations or materials that may be injurious to human health. The methodology section should be
sufficiently descriptive to allow the reviewers to make valid and unambiguous assessment of the project.
Study Design:
This will be a descriptive and quantitative research with cross-sectional design.
a) Study population:
The study will include the children of both sex aged 24 months to 48 months (2-4 years aged children) .
b) Study site:
The survey will be conducted in selected urban locations of Bangladesh at Dhaka city which include
several mullahs of Mirpur,Mohakhali and Mugdha Thana.
C) Sampling Frame:
23
BANGLADESH
DHAKA CITY
MUGDHATHANA
GULSHANTHANA
MIRPURTHANA
MUHALLAH-1(UTTAR MUGDHA)
MUHALLAH-2(MANDA)
MUHALLAH-3(GULSHAN-1)
MUHALLAH-4(MOHAKHALI)
MUHALLAH-5(SENPARA)
MUHALLAH-6(KAZIPARA)
Fig: Different study site of the study
24
MIRPUR
GULSHAN
MUGDHA
Randomization procedure:
Study populations are children of 2-4 years old age. They will be selected by individual randomization.
The subject will be taken randomly from the urban areas of Dhaka city which include different muhallahs
of Mirpur,Mohakhali and Mugdha Thana. Two muhallahs will be selected randomly from each Thana
and 35 to 30 sample (Total sample size is 189) will be collected from each muhallha.
(d) Baseline Data Collection:
Socioeconomic status, family size, and nutritional practices, past health history, illness of the last month
will be collected by pre-structured questionnaire and all these information will be collected from the
mothers of the children included in the study. To determine nutritional status, each team will carry height
scale, weight scale and MUAC (Mid upper arm circumference) Tape.Data will be cross checked at the
spot by verification with another researcher who is involved in this study.Information of food intake can
be collected by different methods.The description of some of the different methods are given below:
24 hour dietary recall method:-
In the 24 hour dietary recall, the respondent is asked to remember and report all foods and beverages
consumed in the preceding day. The recall typically is conducted by personal interview or, more recently,
by telephone [46,47],either computer assisted [48] or using a paper an pencil form. A quality control
system to minimize error and increase reliability of interviewing and 24 hour recalls is essential [47, 49,
50-53]. Direct coding of the foods reported during the interview is now possible with computerized
software systems. The potential benefits of automated software include substantial cost reductions for
processing dietary data, and greater standardization of interview [54].
The main weakness of the 24 hours recall approach is that individuals may not report their food
consumption accurately for various reasons related to memory and the interview situation. Because most
individuals diets vary greatly from day to day, it is not appropriate to use data from a single 24 hour recall
to characterize an individuals usual diet. Neither should a single days intake , be it a recall or food records
, be used to estimate the proportion of the population that has adequate or inadequate diets ( e.g; the
proportion of individuals with less than 30% of energy from fat or who are deficient in vitamin C
intake )[55]. This is variation not only between people in usual diet , but also from day-to-day for each
persons). The principle use of a single 24 hours recall is to describe the average dietary intake of a group
because the means are robust and unaffected by within-person variation. Multiple days of recalls or
records can better asses the individuals usual intake and population distributions , but require special
stastical procedures designed for that purpose [56,57].
25
The validity of the 24hour dietary recall has been studied by comparing respondents reported of intake
either with intakes unobtrusively recorded /weighed by trained observers or with biological markers. In
general group mean nutrient estimates from 24hours recalls have been found to be similar to observed
intakes [58], although respondents with lower observed intakes have intended to over report and those
with higher observed intakes have tended to underreport their intakes [58]. Similar to finding for food
records , biological markers such as doubly labeled water and urinary nitrogen show a tendency toward
underreporting of energy and protein in the range of 13-24% for 24 hours dietary recalls [59]. One
study , however , found over reporting of BMI [60]. In national dietary surveys, data suggest that
underreporting may affect up to 15% of all 24hour recall [61].Under reporters tend to report fewer
numbers of foods , fewer mentions of food consumed and smaller portion sizes across a wide range of
food groups and tend to report more frequent intakes of low fat /diet foods and less frequent intakes of fat
added to foods [62]. Fact such as obesity,gender, social desirability ,restrained eating, education, literacy,
perceived health statas and race/ethnicity have been shown in various studies to be related to
underreporting in recalls [62-64].
Food frequency method:
The Food frequency approach asks to respondents to report their usual frequency of consumption of each
food from a list of foods for a specific period (65-67).Information is collected on frequency and
sometimes portion size, but little detail is collected on their characteristics of the foods eaten, such as the
methods of working Or the combination of food in the meals. To estimate relative or absolute nutrient
intake, many food frequency questionnaires (FFQs), also incorporate portion size questions. Overall
nutrient intake estimates are derived by summing ,overall foods , the products of the reported frequency
of each food by the amount of nutrient in a specified ( or assumed ) serving of that food.There are many
FFQ instruments, and many continue to adopted and developed for different population and different
purposes. Among those validated and commonly used for U.S adults are the health habit and history
Questionnaire (HHHQ) or Block Questionnaire [68-74], the Fred Hutchinson Cancer Research center
food frequency Questionnaire ( a revised HHHQ) [75], and the Harvard university F. Fre. Qu. Or Willetl
qu.[76-80]. Comparisons between the widely usea Block and Willetl instruments have been conducted
indicating differences in estimates for same nutrients [81-83]. A new instrument, the diet history
Questionnaire , developed and in use at the National Cancer Institute was designed with an emphasis on
cognitive case for respondents [84-86] . Other instruments have been developed for specific populations.
26
In this study the information of food intake of 2-4 years old children will be collected by 24 hours
recall method.
Qualitative data collection:
Qualitative data will be collected through focus group discussion (FDG) and in depth interview .After
collection of baseline information, Focus Groups Discussion (FGD) will be conducted to understand the
perception and knowledge gap on:
Child nutrition and growth
Dietary intake of children
Micronutrients rich food for children
Ways of improvement of child nutrition
Quantitative data collection:
Two types of quantitative data will be collected in the study:
1. Anthropometry: Weight will be determined using weighing scale (sensitivity 100g), height will be
measured by height scale with precision of 1 cm, and MUAC will be collected using TALC
(Teaching Aid at Low Cost) tape with precision of 1 mm. Anthropometry data will be collected on
children nutritional status.
2. Structured questionnaire: Personal hygiene, health seeking behaviour and morbidity data will be
collected by administration of structured questionnaire.
e) Questionnaire development:
Before preparation of questionnaire secondary documents after first field been reviewed and the
questionnaire has been finalized. Later on after field test it has been finalized. A questionnaire, for the
study was used, that consists of-
Identification of children aged 2-4 years.
Socio-economic factors.
Feeding practice of child.
Caring practice of child.
Disease controls of child
f) Field Test: Field test will be conducted after designing the questionnaire. During the field test, each
investigator will conduct adequate samples.
g) Quality Control:27
Project supervisor will supervise systematic data collection in 5% random cases. All collected data will
be standardized monthly by the supervisor. Each subject of the study will be recorded file of events and
kept with confidentiality.
h) Data editing, coding, entry :
As soon as the data is collected will be edited by the study investigators, coding rightly and will be
entered using SPSS/PCT software.
i) Data Analysis:
Data will analyze by using SPSS version 12. Nutritional status will be using calculated WHO Anthro
software. Height-for-age, weight-for-age, and weight-for-height z-scores will be obtained by the program.
j) Thesis Preparation:
Based on findings of date, the thesis prepared and submitted accordingly.
Inclusion Criteria:
1. Children aged 2 to 4 years and mothers of the children willing to participate in the study.
Exclusion Criteria:
1. Children out of the specified age groups.
2. Caregivers who disagreed.
3. Parents who are absent in the house.
4. Children who are suffer from illness more than 2 weeks.
Study Procedure:
Protocol writing and approval
Questionnaire development
Pre testing
Selecting Population and study site
Sample size Calculation
Data collection Quantitative and qualitative
Data entry and editing, coding
28
Data analysis
Thesis writing
Collection of information:
Consent will be taken from the mothers fulfilling the eligibility criteria and agreeing to participate as
indicated by signing on an informed consent form. Information on current dietary pattern, nutritional
status, food intake of the children will be collected. Information on socio-economic status, years of
formal education of the mother and her spouse, history of illness in last one month, type of housing, land
ownership of the family, water source, sanitation arrangement and waste disposal will also be collected
from the mother at enrolment through a structured and pre-tested questionnaire. Information of food
intake of children will be collected by 24 hours recall method.
In-depth interview will be conducted with the mothers to understand their perceptions and knowledge
gaps on:
1. The perceptions about food security of children, feeding practice and pattern.
2. Perceptions on advantages of complementary feeding.
3. Frequency and quality of diet, micronutrient in food its important.
4. Perception on personal hygiene and sanitation.
5. Perception on causes and consequences of malnutrition of children.
In-depth interview will be done with the distinguish mothers to evaluate the change in perception and
behaviour if any.
Quality control measures:
Project investigators will supervise systematic data collection in randomly selected 25% of the
participants. Anthropometric data will be standardized (WHO growth chart) by trained nutritionist. The
principle investigator will check the data collection and check records of every file. In the event any
discrepancy is identified, the respective health worker will be informed and assisted by supervisor to
correct relevant data. For each participant of the study a separate file will be maintained at the project
29
office for recording events of interest. Data will be checked by statistical software (SPSS software) after
collection and before analysis
Sample Size Calculation and Outcome Variable(s)
Sample size calculation:
Assumption: 2-4 years old children will have 60% of RDA (i.e. - 40% less) of iron/vitamin
A/ Zinc intake, then the formula will be used as [87]-
{u √ [ π ( 1- π )] + v √ [π0 ( 1- π0 ) ] }²n = (π - π0)²
Here,
u = 1.28 (If power 90%)
v = 1.96 (Significance level 5%)
π 0 = 60% = 0.6
π = 40% = 0.4
= 125.46 126
Design effect 1.5 Sample size = 126 x 1.5= 189
Variable List:
30
1. Child feeding time, quantity and quality
2. Child caring practice
3. Food intake
4. Water source
5. Mother/Care taker’s perception
4. Socio economic status of the family
6. Educational status of the mother and father
7. Height of the child
8. Weight of the child.
9. Measurement of the MUAC (Mid upper arm circumference)
Description of the variables:
1. Feeding time of the children:
We should find out that the children are having their food timely or not. Feeding time for the
children aged 2-4 years may be thrice a day or more.
2. Food intake:
It means that what type of foods are usually taken by the children and also to find out that foods are
riched with micronutrients or not.
3. Water source:
We should also consider the source of water that is taken by the children. Because if the water is not
pure enough then it may create so many diseases in children.
4. Socio economic status of the family:
The socio-economic status will be estimated from four types of proxy indicators such as roof materials,
possession of electrical and mechanical items and last month’s total household expenditure. The
conditions set for constructing three types of socio-economic status (SES) are as follows:
High SES includes: 1. Pucca or tin/CI sheet roof with at least 10 ft. height + at least one of
motor cycle/sewing machine/water pump + at least one of
radio/watch/clock; or
2. Monthly expenditure more than Tk. 10000.00
Medium SES includes: 1. Tin/CI sheet roof with at least 8 ft. height = at least one of
radio/watch/clock; or,
2. Tin/CI sheet roof with at least 8 ft. height + at least one of motor
cycle/sewing machine/water pump; or,
3. Monthly expenditure more than Tk. 5,000.00.
31
Low SES includes: 1. Bamboo/straw roof; or,
2. Tin/CI sheet roof with less than 8 ft. height + no mechanical/electrical
goods; or,
3. Monthly expenditure equal or less than Tk. 2500.00.(14)
5. Educational status of the mother:
We should take information about the children’s mother educational status because an educated mother
can take care of her children more properly. For example, an educated mother have the knowledge about
the micronutrients containing foods and that’s why she can provide the micronutrients containing foods
to her children.
6. CLASSIFICATION OF NUTRITIONAL STATUS:
Standard deviation score (SD score or Z-score):
For conducting 1995-96 anthropometric measurements we have followed the standard deviation score or
Z-score classification . Z-score is multiple of standard deviation . It is estimated by taking median value
of the reference population, divided by the standard deviation for the reference population[88].
Z-score or SD score = Observed value-median reference value
Standard deviation of reference population
Earlier experts in this area used to treat those whose weight for height were within 80 percent of median
and those whose height for age were within 90 percent of the median of the reference population as being
normal in terms of their physical development . Those whose weight for height was more than 80 percent
and those whose height for age was more than 90 percent of the median were treated as being abnormal .
Classification of population of determining malnourishments in the above manner was known as
waterlow classification . According to WHO (1995) “The main disadvantage of this system is the lack of
exact correspondence with a fixed point of distribution across age or height status”. For example ,
depending on the child’s age ,80 percent of the median weight-for-age might be above or below 2Z-score
in terms of health this would results in different classification to risk[88] .
Another method was adopted earlier to estimate the extent of underweight known as GOMEZ
method .This was not satisfactory method for classifying the incidence of underweight among children .
Since Z-score classification can be used for all type of anthropometric measurements for obtaining
accurate data on under nourishment , experts now use Z-score instead of the other methods for
determination stunting, underweight and wasting [88].
32
Children whose scores according to anthropometric indices were found to be less than 2SD or below the
reference ,have been classified as being physically retarded[89]. . The scores for severe and
moderate ,stunting ,wasting and underweight are given below :-
Height for age:-
Stunting or chronic malnutrition: -2SD or below.
Moderate : -2SD to -2.99 SD.
Severe : -3SD or below.
Weight for height:
Wasting or acute malnutrition : -2SD or below.
Moderate : -2SD to -2.99 SD.
Severe : -3SD or below.
Weight for age:
As well as acute malnutrition : -2SD or below.
Moderate : -2SD to -2.99 SD.
Severe : -3SD or below.
Mid upper Arm Circumference (MUAC):
Mid upper Arm Circumference is used as a measure for identifying children with protein-energy-
malnutrition (PEM).The MUAC in well nourished group of children does not differ appreciably among
12-59 months old children[88] .
Body mass index:
BMI indicator is calculating by dividing weight in kilogram by the square of height in meters. In adults it
is used with age to define over-weight or thinness. It has also been used for older children and
adolescents but not widely used for children because of its variation with age. Classification of
nutritional status by Body Mass Index as shown below was done according to WHO,1995.
Recommended cut off values for BMI :
Indicator Cut off values
Thinness or low BMI for age <5 th percentile
33
At high risk of over weight or high BMI
for age.
>85 th percentile
Height and weight for children:
In this section we shall be dealing with the nutritional of surveyed population of 2-4 years aged groups.
Facilities Available
Describe the availability of physical facilities at the place where the study will be carried out. For clinical
and laboratory-based studies, indicate the provision of hospital and other types of patient’s care facilities
and adequate laboratory support. Point out the laboratory facilities and major equipment that will be
required for the study. For field studies, describe the field area including its size, population, and means
of communications.
a) Anthropometric equipments (Weighing scale, stadiometer, MUAC tape).
b) Office space available.
c) Computer support available.
d) Skilled expertise available (nutritionist, immunologist, technicians, computer, programmer, data
analyst).
e) Library available.
f) Internet service available.
Data Safety Monitoring Plan (DSMP)
All clinical investigations (biomedical and behavioural intervention research protocols) should include the Data and Safety Monitoring Plan (DSMP) to provide the overall framework for the research protocol’s data and safety monitoring. It is not necessary that the DSMP covers all possible aspects of each elements. When designing an appropriate DSMP, the following should be kept in mind.
a) All investigations require monitoring;b) The benefits of the investigation should outweigh the risks;c) The monitoring plan should commensurate with risk; andd) Monitoring should be with the size and complexity of the investigation.
Safety monitoring is defined as any process during clinical trails that involves the review of accumulated outcome data for groups of patients to determine if any treatment procedure practised should be altered or not.
Full confidentiality of data will be ensured, and will be available only to the investigators and Ethical
Review Committee of ICDDR,B. All data would be stored in locked cabinet at ICDDR,B, and none other
34
than the investigators of the study and the Ethical Review Committee of ICDDR,B, which protects the
interest of research participants, will have an access to them. We will not use the names or identities of
the participants during data analyses and sharing results with others; while entering data onto computer,
personal identifiers will be replaced by a unique code number for each of the participant pairs. All data
will remain property of ICDDR,B.
Quality Control of the study:
Quality assurance will be done through adequate training of the study staff, standardization of the
procedures and supervision by investigators. A major responsibility of ICDDR, B would be to maintain
the quality of data and its analysis. The quality control team will re-train the survey team, if necessary.
Data Safety:
Data will be kept confidential and will not be available to anybody except the investigators. Data
collecting personnel will be advised and motivated to keep the information confidential, and data may be
shared only with respective respondent or participating parents/ primary caregivers’ if requested. Data
will not carry the name of the participants and instead codes will be entered onto computer.
Data Analysis
Describe plans for data analysis. Indicate whether data will be analyzed by the investigators themselves or by other professionals. Specify what statistical software packages will be used and if the study is blinded, when the code will be opened. For clinical trials, indicate if interim data analysis will be required to monitor further progress of the study.
Data will analyze by using SPSS version 12. Nutritional status will be using calculated WHO Anthro
software. Height-for-age, weight-for-age, and weight-for-height z-scores will be obtained by the program.
Statistical significance will be accept at 5% level.
Ethical Assurance for Protection of Human Rights
Describe in the space provided the justifications for conducting this research in human subjects. If the study needs observations on sick individuals, provide sufficient reasons for using them. Indicate how subject’s rights are protected and if there is any benefit or risk to each subject of the study.
There will be no ethical problem to enroll selected micronutrient. Consent will be taken from each of the
mothers having a baby aged 2-4 years after informing them the objective of the study, the methods, the
risks and benefits, confidential handling of personal information, and the voluntary nature of participation
and the rights to withdraw from the study. The study will receive normal care and advice provided by the
facility concerned.
35
Use of Animals
Describe in the space provided the type and species of animals that will be used in the study. Justify with reasons the use of particular animal species in the experiment and the compliance of the animal ethical guidelines for conducting the proposed procedures.
No animals will be used in this study.
Literature Cited
Identify all cited references to published literature in the text by number in parentheses. List all cited references sequentially as they appear in the text. For unpublished references, provide complete information in the text and do not include them in the list of Literature Cited. There is no page limit for this section, however exercise judgment in assessing the “standard” length.
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S.(1991). An evaluation of a food frequency questionnaire for assessing dietary intake of specific
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recall methods in studies of nutrient intake of low-income pregnant women. J. Am. Diet.
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questionnaire: The reduce Block and Willett questionnaires differ in ranking on nutrient intake.
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82) Caan, B. J., Slattery,M L., Potter, J., Quesnberry, C. P. J., Coates, A. O., Schaffer, D. M.(1998).
Comparison of the Block and the Willett self-administered semiquantitative food frequency
questionnaires with an interviewer-administered dietary history. Am. J. Epidemiol.148,1137-
1147.
83) McCann, S. E., Marshall, J. R., Trevisan, M., Russell, M., Multi, P., Marcovic, N., Chan, A. W.,
and Freudenheim, J. J.(1999). Recent alcohol intake as estimated by the Health Habits and
History questionnaire, the Harvard Semiquantitative Food Frequency questionnaire, and a more
detailed alcohol intake questionnaire. Am. J. Epidemiol.150,334-340.
84) Subar, A. F., Thompson, F. E., Smith, A. F., Jobe, J. B., Ziegler, R. G., Potischman, N.,
Schatzkin, A., Hartman, A., Swanson, C., Kruse, L., Hayes, R. B., Riedel-Lewis, D., and Harlan,
L. C.(1995). Improving food frequency questionnaire: A qualitative approach using cognitive
interviewing. J. Am. Diet. Assoc.95,781-788.
42
85) Subar, A. F., Ziegler, R. G., Thompson, F. E., Weissfeld, J. L., Reding, D., Kavounis, K. H., and
Hayes, R. B.(2000). Is shorter always better?: Relative importance of dietary questionnaire length
and cognitive ease on response rates and data quality. Am. J. Epidemiol.153,404-409.
86) MARtorell R, Scrimsho NS (eds) (1995). The effects of improved nutrition in early childhood:
The Institute of Nutrition of Central America and Panama (INCAP) Follow-up Study. Journal of
Nutrition 125(4s), April Supplement
87) Kirkwood BR.Essentials Medical Statistics (1st edition),Oxford: Blanckwell, Scientific
Publications,1988.
88) Roy. S .k,Jahan khurseda,Hossain Mosharaff; Nature and Extent malnutrition in Bangladesh
National Nutrition Survey 1995-1996
Dissemination and Use of Findings
Describe explicitly the plans for disseminating the accomplished results. Describe what type of publication is anticipated: working papers, internal (institutional) publication, international publications, international conferences and agencies, workshops etc. Mention if the project is linked to the Government of the People’s Republic of Bangladesh through a training programme.
Results of the study and their interpretations will be used in developing thesis for the students conducting
the study, and disseminated at seminar/conference to peer scientists, policy makers, NGO officials,
government officials. The result will be also be used for thesis, and will and will be published in peer-
reviewed journals for sharing with larger scientific community. Final report will be published for
dissemination among allied agencies and institutions. Knowledge generated from this study will be
potentially used to improve the nutritional status of children in different Socio-economic status (SES) in
Urban and semi-urban area.
Collaborative Arrangements
Describe briefly if this study involves any scientific, administrative, fiscal, or programmatic arrangements with other national or international organizations or individuals. Indicate the nature and extent of collaboration and include a letter of agreement between the applicant or his/her organization and the collaborating organization.
This study does not involve collaboration with any organization outside of ICDDR,B.
43
44
Biography of the Investigators Give biographical data in the following table for key personnel including the Principal Investigator. Use a photocopy of this page for each investigator.
(Note: Biography of the external Investigators may, however, be submitted in the format as convenient to them)
1 Name: Dr. S.K. Roy
2 Present Position: : Senior Scientist
3 Educational background: (last degree and diploma & training relevant to the present research proposal)
(last degree and diploma & training relevant to the present research proposal)
F. R. C. P 2007 Royal College of Physician Edinbargh
Ph. D in Nutrition 1987-1990 University of London
Certificate on Food, Nutrition, 1984-1985 London School of Hygiene and Biotechnology and poverty Tropical Medicine, UK & UNU
M.Sc. in Human Nutrition 1983-1984 London School of Hygiene and Tropical Medicine, UK
MBBS Dhaka 1973 Dhaka Medical College, University of Dhaka
4.0 List of ongoing research protocols (start and end dates; and percentage of time)
4.1. As Principal Investigator
Protocol Number Starting date End date Percentage of time
4.2. As Co-Principal Investigator
Protocol Number Starting date End date Percentage of time
4.3. As Co-Investigator
45
Protocol Number Starting date End date Percentage of time
5 Publications
Types of publications Numbersa. Original scientific papers in peer-review journals 60b. Peer reviewed articles and book chapters 9c. Papers in conference proceedings 30d. Letters, editorials, annotations, and abstracts in peer-reviewed journals e. Working papers f. Monographs
6 Five recent publications including publications relevant to the present research protocol1)Roy SK, Khatun W, Azim T, Raqib R, Chakraborty B. Synergistic effect of vitamin A and zinc on nutritional status and growth in 6-36 months age group. In: proceedings of the symposium on Nutrition in late infancy and early childhood (6-24 months), Nutrition Foundation of India. 2006
2)Roy S K, AM Tomkins, SM Akrauzzman, KE Islam, G Ara, W Khatun, S P Jolly. Impact of Zinc supplementation on subsequent morbidity and growth in Bangladeshi children with persistent diarrhoea. J Health Popul Nutr 2007 Mar;25(1):67-74
3)Roy SK, Raqib R, Khatun W, Azim T, Chowdhury R, Fuchs GJ, Sack DA. Zinc supplementation in the management of shigellosis in malnourished children in Bangladesh. EJCN March 2007; 1-7
4) Roy SK, Hossain M.J, W.Khatun, Chakraborty B, Chowdhury S, Begum A, Muneer
SME, Shafique S, Khanam M, Chowdhury R. Zinc supplementation in children in cholera in
Bangladesh: Randomised controlled trial; BMJ January 2008: online publication
5) Roy SK, Jolly S P, Shafique S , Fuchs G J , Mahmud Z, Chakraborty B, and Roy S . Prevention of malnutrition among young children in rural Bangladesh by a food–health-care educational intervention: A randomized controlled trial; Food and Nutrition Bulletin; January 2008; vol 28 (4); 375-383.
Biography of the InvestigatorsGive biographical data in the following table for key personnel including the Principal Investigator. Use a photocopy of this page for each investigator.
(Note: Biography of the external Investigators may, however, be submitted in the format as convenient to them)
46
1 Name: Dr.Sufia Islam,
2 Present Position: Associate Professor
3 Educational background: (last degree and diploma & training relevant to the present research proposal) Ph.D. in Pharmacology, Dhaka University in collaboration with CNAM, Paris, France4.0 List of ongoing research protocols (start and end dates; and percentage of time)
4.4. As Principal Investigator
Protocol Number Starting date End date Percentage of time
4.5. As Co-Principal Investigator
Protocol Number Starting date End date Percentage of time
4.6. As Co-Investigator
Protocol Number Starting date End date Percentage of time
5 Publications
Types of publications Numbersg. Original scientific papers in peer-review journals h. Peer reviewed articles and book chapters i. Papers in conference proceedings j. Letters, editorials, annotations, and abstracts in peer-reviewed journals k. Working papers l. Monographs
6 Five recent publications including publications relevant to the present research protocol
1)
2)
47
3)
4)
5)
Biography of the InvestigatorsGive biographical data in the following table for key personnel including the Principal Investigator. Use a photocopy of this page for each investigator.
(Note: Biography of the external Investigators may, however, be submitted in the format as convenient to them)
1 Name:
2 Present Position:
3 Educational background: (last degree and diploma & training relevant to the present research proposal)
4.0 List of ongoing research protocols (start and end dates; and percentage of time)
4.7. As Principal Investigator
Protocol Number Starting date End date Percentage of time
4.8. As Co-Principal Investigator
Protocol Number Starting date End date Percentage of time
4.9. As Co-Investigator
Protocol Number Starting date End date Percentage of time
48
5 Publications
Types of publications Numbersm. Original scientific papers in peer-review journals n. Peer reviewed articles and book chapters o. Papers in conference proceedings p. Letters, editorials, annotations, and abstracts in peer-reviewed journals q. Working papers r. Monographs
6 Five recent publications including publications relevant to the present research protocol
1)
2)
3)
4)
5)
Budget Justifications
Please provide one page statement justifying the budgeted amount for each major item. Justify use of human resources, major equipment, and laboratory services.
Research protocol title: A study on selected micronutrient intake of 2-4 years old children into lower socio economic status (SES).
BudgetDetailed Budget
Personnel Invistigator
Money(Taka)
1.Travela) Sample selection(--days) 8000.00b) Home visit 4000.00
2.Printing & Publication
a)Photocopy 3000.00b)Typing 1000.00c)Printing 2000.00d)Binding 1000.00
3.Computer 1000.004.Stationars (Paper,Pen,Pencil,Eraser,Scale,Files,Fluid,etc.) 500.00
49
5.Miscellaneous 500.00TOTAL 21000.00
Other SupportDescribe sources, amount, duration, and grant number of all other research funding currently granted to PI or under consideration.
50
Check-List
CHECK-LIST FOR SUBMISSION OF RESEARCH PROTOCOLFOR CONSIDERATION OF RESEARCH REVIEW COMMITTEE (RRC)
[Please check (X) appropriate box]
1. Has the proposal been reviewed, discussed and cleared at the Division level?
Yes No
If No, please clarify the reasons:
2. Has the proposal been peer-reviewed externally?
Yes No
If the answer is ‘No’, please explain the reasons:
If yes, have the external reviews’ comments and their responses been attached
Yes No
3. Has the budget been cleared by Finance Department?
Yes No
If the answer is ‘No’, reasons thereof be indicated:
4. Does the study involve any procedure employing hazardous materials, or equipments?
Yes No
If ‘Yes’, fill the necessary form.
______________ _________ Signature of the Principal Investigator Date
51
Section 1: Identification of ChildrenSection 1: Identification of Children
Starting time: HourStarting time: Hour
MinutesMinutes
Division CodeDivision Code : : Name : ______________________________Name : ______________________________
District CodeDistrict Code : : Name : ______________________________Name : ______________________________
Upazila CodeUpazila Code :: Name : ______________________________Name : ______________________________
Union CodeUnion Code :: Name : ______________________________Name : ______________________________
Mouza CodeMouza Code : : Name : ______________________________Name : ______________________________
Village NameVillage Name : : __________________________________________________________
Bari NameBari Name : _____________________________: _____________________________
Mother’s Name: Mother’s Name: __________________________________________________________
Child’s NameChild’s Name : : __________________________________________________________
Sex Sex :: (1= Male, 2= Female)(1= Male, 2= Female)
Date of Birth : : : : : dd mm yyyy dd mm yyyy
Present AgePresent Age :: : : : : dd mm yy dd mm yy
Section 2: General information:Section 2: General information:
Q#Q# Questions and filters Categories Code
Q 1: How old are you? Age……………………………………
Q 2: Have you ever attended School?
Yes……….…………………………….01No…………….......................................02
52
Q 3: What type of Schooling have you last attended?
School/College/University……….…….01Madrasah,……………………………...02Non-formal………………………….....03 could just read or write or both …...…..04Don’t Know…………………………....05
Q 4: What are the Education period of yours?
Below class 5…………………………..01Class 5-10……………………………...02S.S.C …………………………………..03H.S.C ………………………………….04Vocational Course …………………….05 B.A/B.Com/B.S.S (Pass)………………06B.Sc.(Hons.)…………………………...07M.Sc…………………………………...08Others………………………………….09
Q 5: What is the occupation of yours?
Govt. Service………………................ 01Non-Govt. Service............................... 02Teaching/Tuition.................................. 03Housewife………….............................. 04Garments worker…............................... 05Work in house……............................... 06Others ………….............................…...07 (Specify)
Section 3: Information about Socio-economic Status:
Q#Q# Questions and filters Categories Code
Q 6: What is your What is your Husband’s occupation?Husband’s occupation?
Govt. Service………………................ 01Non-Govt. Service............................... 02Teaching/Tuition.................................. 03Farmer (Self-employed)………….............................. 04Farmer....................................................05Garments worker…............................... 06Day Labor...............................................07Rickshaw puller/Boatman/Van driver....08Business.................................................09Small Small Business.......................................10Fisherman..............................................11CarpenterCarpenter ......……............................... 12Others ………….............................…...13 (Specify)
Q 7: What are the materials What are the materials of roof, wall and floor of roof, wall and floor of your (main) of your (main) dwelling unit?dwelling unit?
Material Roof Wall FloorLeaves/straw 1 1Mud 2 2Bamboo 3 3 3Tin 4 4Pucca/cement/tiles 5 5 5
53
Q 8: What is your monthly What is your monthly family income?family income?
__ , __ __, __ __ __ /= Tk.__ , __ __, __ __ __ /= Tk.
Q 9: Does your household Does your household own any land?own any land?
Yes……….…………………………….01No…………….......................................02
Q 10:Q 10: Source of Washing /bathing water
Tap……….............................................01Tubewell…............................................02Pond……….....................................….03Ditch/Canal/Lake…..............................04River/Fountain….............................….05Rain water……...........................……..06Others…………............................……07 (Specify)
Q 11: Source of drinking water
Tap……….............................................01Tubewell…............................................02Pond……….....................................….03Ditch/Canal/Lake…..............................04River/Fountain….............................….05Rain water……...........................……..06Others…………............................……07 (Specify)
Q 12: Does your Does your household/any memberhousehold/any member of your household of your household have?have?
Yes Yes No NoElectricityElectricity........................................................1....1..............22Almirah/WardrobeAlmirah/Wardrobe................................11..............22TableTable............................................................................11..............22Chair/bench Chair/bench ....................................................11..............22Dining tableDining table......................................................11..............22Khat/ChowkiKhat/Chowki..................................................11..............22Functioning radio/Functioning radio/Two-in-oneTwo-in-one........................................................11..............22Functioning TVFunctioning TV..........................................11..............22BicycleBicycle....................................................................11..............22Motor bikeMotor bike..........................................................11..............22Sewing machineSewing machine........................................11..............22Electric fanElectric fan........................................................11..............22Telephone (cell/land)Telephone (cell/land)........................11..............22
Q 13: Wastage type Dustbin .................................................01In hole ..................................................02
Q 14: Where is the (main water source) located?
Inside the house………………….........01Outside the bari……………………….02Others…………............................……03 (Specify)
Q 15: What kind of toilet Facility does your household have?
Septic tank/Modern latrine…………...01Slab Latrin……………………....….02Pit Latrin ………………………......03Hanging Latrin………………..…..…..04Open latrine…………………….....….05Bush/field/Yard…………………........06
54
Others…………………………….......07 (Specify)
Q 16: Do you share this facility with other household?
Yes……….…………………………….01No…………….......................................02
Section 4: Anthropometric Measurement of Children:
Q# Categories Figure UnitUnit
Q17: Height (cm)
……………………………………….
.. cm.cm.
Q 18: Body Weight (kg)
……………………………........
.. Kg.
Q 19: MUAC (cm)
……………………………………….
.. cm.
Section 5: Child feeding practices:
Q# Questions and filters Categories Code
Q20 Did you breastfeed your child?
Yes……….…………………………….01No…………….......................................02
Q21 Did you feed colostrum to Did you feed colostrum to your child?your child?
Yes……….…………………………….01No…………….......................................02
Q22 When did you initiateWhen did you initiate of breast-milk just after birth?
Minutes Minutes ....................................................................Hour.........................................Hour.........................................Days.........................................Days......................................... (Specify the time) (Specify the time)
Q23 Did you feed honey, plain water, and sugar water Immediately after his or her birth?
Yes……….…………………………….01No…………….......................................02
Q24 How long did you breastfeed to your child?
Days Days ..................................................................................................MonthsMonths............................................................................................Year...................................................Year................................................... (Specify the time) (Specify the time)
Q25 Did you have separate feeding pots for the child?
Yes……….…………………………….01No…………….......................................02
Q26 Which type of pots do you use for feeding your baby?
Bottle feeding……………….................01Clay/Bowl…………………..................02Crystal pot…………………..................03Earthen basin………………..................04Tinplate……………………..................05Plastic Plate…………………................06Steel plate……………………...............07
55
Others…………………………….........08 (Specify)
Q 27 What type of salt is used for What type of salt is used for cooking by your household?cooking by your household?
Packet (Iodized) salt..............................01Packet (Iodized) salt..............................01Unpacked (Non-iodized) salt................02Unpacked (Non-iodized) salt................02
Q 28 Do you cook food specially for your child
Yes……….…………………………….01No…………….......................................02
Q 29 Do you use more oil in your baby’s food?
Yes……….…………………………….01No…………….......................................02
Q 30 Do you know how to prepare kichuri?
Yes……….…………………………….01No…………….......................................02
Q 31 How many times have you cook kichuri for your child?
1 time………..........................................012 time………..........................................023 time………..........................................03Others….................................................04 (Specify)
Q 32 How many times the child eat kichuri per day?
1 time………..........................................012 time………..........................................023 time………..........................................03Others….................................................04 (Specify
Section 6:Caring Practices
Q# Questions and filters Categories Code
Q 33:Who is the main caregiver of the child?
Mother….............................................01Caretaker….....................................…02Others……....................................…..03 (Specify)
Q 34:How many hours the child sleep?
6-8 hours…....................................….018-10hours…........................................02Others………......................................03 (Specify)
Q 35:
What do you do when the child deny to eat?
Play with the child…..........................01By singing…………..........................02By gossiping……….......................…03By telling History…...........................04Others…………….............................05 (Specify).
Q 36 Do you gossip with the child?
Yes……….…………………………….01No…………….......................................02
Q37 :Do you Encourage your child to play?
Yes……….…………………………….01No…………….......................................02
Q38 Do you play with the child?
Yes……….…………………………….01No…………….......................................02
Q 39 To whom child play with? Mother……...........................................01Father……............................................02Brother..............................................…04Cousin……...........................................05Caretaker…...........................................06Grandparents.........................................07
56
Others……........................................…08 (Specify)
Q 40 DO you take your child to outside home
Yes……….…………………………….01No…………….......................................02
Q 41 Does child use shoe out side of the room?
Yes……….…………………………….01No…………….......................................02
Q 42 Dose the child brushes teeth twice a day?
Yes……….…………………………….01No…………….......................................02
Q 43 Do you cut your child’s nail per week?
Yes……….…………………………….01No…………….......................................02
Q 44 Does the child take a bath per day?
Yes……….…………………………….01No…………….......................................02
Q45 Do you maintain hygiene? Yes……….…………………………….01No…………….......................................02
Q46 Does the child have own plate& glass?
Yes……….…………………………….01No…………….......................................02
Q47 What does things the child do about study?
Rhymes….........................................…..01Story..........................................……….02Limbs……….........................................03Counting…........................................….04Math………...........................................05Painting…….....................................….06Larn about Environmental element...................…..07Others……............................................08 (Specify)
Section 7: DISEASE CONTROL:
Q# Questions and filters Categories Code
Q 48 Does the child have taken the first six vaccines?
Yes……….…………………………….01No…………….......................................02
Q 49 Does the child have taken polio vaccine?
Yes……….…………………………….01No…………….......................................02
Q 50 Did the child become sick with in last 15 days?
Yes……….…………………………….01No…………….......................................02
Q 51 If yes then which type? Fever…...................................................01Cough/Cold…........................................02Diarrhoea/dysentery…….......................03Vomiting/Stomach-ache…......................04Pneumonia………..................................05
57
Ear Infection….......................................06Skin problem…......................................07RTI…………......................................…08Others………..........................................09(Specify)
Q 52 Within how many days the child has taken to the doctor after become sick?
Number of days………………………… (Specify)
Q 53 Does child use soap after coming from toilet?
Yes……….…………………………….01No…………….......................................02
Q 54 Does child use soap before eating?
Yes……….…………………………….01No…………….......................................02
Q 55 How long your child had been ill at the past?
Number of days………………………… (Specify)
Q 56 Still have any diseases in your child
Yes……….…………………………….01No…………….......................................02
Q 57 If yes, then what are the diseases that have your child?
Fever…...................................................01Cough/Cold…........................................02Diarrhoea/dysentery…….......................03Vomiting/Stomach-ache….....................................................04Pneumonia………..................................05Ear Infection….......................................06Skin problem…......................................07RTI…………......................................…08Others……….........................................09(Specify)
Q 58 How long your child are sick?
Number of days………………………… (Specify)
Q 59 Is your child in Hospitalization for this sickness?
Yes……….…………………………….01No…………….......................................02
Q 60 How long your child are Hospitalized?
Number of days………………………… (Specify)
Section 8: Food intake information of child for the day before interview
58
(24 hour recall method)
No Name of the food Quantity Frequency
01 Rice (cup)
02 Bread/ chapati (piece)
03 Pulse (cup)
04 Meat / Fish (piece)
05 Egg (piece)
06 Milk (Cup)
07 Khichuri (Normal)
08 Khichuri (Formulated cup)
09 Leafy vegetable (cup)
10 Fruits (piece)
11 Halua/suji/Firni (cup)
12 Chira/ Muri (cup)
13 Biscuit
14 Sugar/Gur (tea spoon)
15 Oil (tea spoon)
16 Others (identify)
Ask-1:wkï mbv³Kib
59
ïi“i mgq:N›Uvïi“i mgq:N›UvwgwbU wgwbU
wefvM †KvWwefvM †KvW: : bvgbvg: ______________________________: ______________________________
‡Rjv †KvW‡Rjv †KvW: : bvgbvg ______________________________ ______________________________
Dc‡Rjv †KvWDc‡Rjv †KvW:: bvgbvg: ______________________________: ______________________________
BDwbqbBDwbqb †KvW†KvW:: bvgbvg: ______________________________: ______________________________
‡gŠRv †KvW‡gŠRv †KvW: : bvgbvg: ______________________________: ______________________________
evwoi bvg evwoi bvg : : __________________________________________________________
evwoi b¤^i:evwoi b¤^i: _____________________________ _____________________________
gv‡qi bvggv‡qi bvg: : __________________________________________________________
ev”Pvi bvgev”Pvi bvg: : __________________________________________________________
wj½wj½:: ((1=†g‡q,2=†Q‡j1=†g‡q,2=†Q‡j))Rb¥ ZvwiL: : : : : w`b gvm eQiw`b gvm eQi
eZ©gvb eqmeZ©gvb eqm:: : : : : w`b gvm eQiw`b gvm eQi
Ask-2: mvaviY mvaviY Z_¨:
cÖkcÖkœ bsœ bs ::
cÖkœ ‡kªbx †KvW†KvW
cÖkcÖkœ œ bs:1bs:1
Avcbvi eqm KZ? eqm……………………………………
cÖkcÖkœ œ bs:2bs:2
Avcwb wK ¯‹z‡j †hvM`vb K‡iwQ‡jb?
n¨uv……….…………………………….01bv…………….......................................02
60
cÖkcÖkœ œ bs:3bs:3
‡Kvb ai‡bi ¯‹y‡j Avc‡b ‡k‡l ‡hvM`vb K‡iwQ‡jb?
¯‹zj/K‡jR/wek¦we`¨vjq……….…………….01gv`ªvmv,……………………………..........02Ab-AvbyôvwbK……..……….......................03ïay wjL‡Z A_ev co‡Z cv‡i A_ev DfqB….....04Rv‡b bv…………………………............05Ab¨vb¨……………………………….....06 (wbw`©ó)
cÖkcÖkœ œ bs:4bs:4
Avcbvi wk¶vi &&wbw`©ó wefvM ‡KvbwU?
5g ‡kªbxi bx‡P…………………………..015g-10g ‡kªbx……………………………02Gm,Gm,wm………………………………03GBP,Gm,wm……………………………..04KvwiMwi wk¶v ...…………………………05we,G/we,Kg/…we.Gm.wm(cvm&)..........................06 we,Gm,wm(m¤§vb)……………...…….........07Gg,Gm,wm(m¤§vb)………………………...08Ab¨vb¨………………………………….09 (wbw`©ó)
cÖkcÖkœ œ bs:5bs:5
Avcbvi ‡ckv wK? miKvix PvKzix ………………................ 01‡emiKvix PvKzix............................... ........02wk¶KZv/wUDkbx........................................03M„wnbx…………......................................04Mv‡g©›Um kªwgK …......................................05N‡ii Kv‡Ri †jvK …….............................06 Ab¨vb¨………….............................…...07 (wbw`©ó)
Ask 3:mvgvwRK A©_‰YwZK cÖwZôvi Z_¨:61
cÖkœcÖkœ bs :bs :
cÖkœ ‡kªbx †KvW†KvW
cÖkœcÖkœ bs:6bs:6
Avcbvi ¯^vgxi ‡ckv wK?
miKvix PvKzix ………………................01‡emiKvix PvKzix......................................02wk¶KZv/wUDkbx.................................. . 03K…wlKvR (wb‡Ri Rwg‡Z) .........................04K…wlKvR ...............................................05Mv‡g©›Um kªwgK …...................................06w`b gRyi...............................................07wiKkv/†bŠKv/f¨vb PvjK............................08e¨emvqx.................................................09¶z`ª e¨emvqx...........................................10†R‡j....................................................11wgw¯¿ ......……............................... ......12Ab¨vb¨………….............................…...13 (wbw`©ó)
cÖkœcÖkœ bs:7bs:7
Avcbvi evoxi Qv`, Avcbvi evoxi Qv`, †`qvj Ges †g‡S wK †`qvj Ges †g‡S wK wK Dcv`vb w`‡q wK Dcv`vb w`‡q ˆZix?ˆZix?
Dcv`vb Qv`
‡`qvj
‡g‡S
cvZv/Lo 1 1gvwU 2 2evuk 3 3 3wUb 4 4cvKv/wm‡g›U/UvBjm&
5 5 5
cÖkœcÖkœ bs:8bs:8
Avcbvi cwiev‡ii gvwmK Avq KZ?
__ , __ __, __ __ __ /= __ , __ __, __ __ __ /= UvKv
cÖkœcÖkœ bs:9bs:9
Avcbvi emZevoxwU wK wbR¯^?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0022
cÖkœcÖkœ bs:10bs:10
Kvco KvPvi /†Mvmj Kivi cvwbi Drm wK?
Kj……….............................................01wUDeI‡qj…............................................02cyKzi……….....................................
62
…..03bi`gv/©Lvj/n«`…......................................04b`x/‡dvqviv….............................….........05e„wói cvwb……...........................…….....06Ab¨vb¨………….............................…...07 (wbw`©ó)
cÖkœcÖkœ bs:11bs:11
Lvevi cvwbi Drm wK?
Kj……….............................................01wUDeI‡qj…............................................02cyKzi……….....................................…..03bi`gv/©Lvj/n«`…......................................04b`x/‡dvqviv….............................….........05e„wói cvwb……...........................…….....06Ab¨vb¨………….............................…...07 (wbw`©ó)
cÖkœcÖkœ bs:12bs:12
Avcbvi emZevox‡Z wbæwjwKZ wK wK wRwbm Av‡Q?
nu¨v bv we`y¨r..............................................................11............22Avjgvix/IqvWªe........................11............22‡Uwej..................................................................11............22‡Pqvi/†eb..................................................11............22LvIqvi †Uwej....................................11............22LvU/†PŠwK............................................11............22‡iwWI (mPj)........................................11............22wUwf (mPj)........................................11............22mvB‡Kj............................................................11............22ûÛv..........................................................................11............22‡mjvB †gwkb..................................11............22cvLv........................................................................11............22
‡Uwj‡dvb (‡gvevBj/‡jvKvj)11............................................................................................22
cÖkœcÖkœ bs:13bs:13
Ave©Rbv ¶q Wv÷web...................................................01M‡©Z........................................................02
cÖkœcÖkœ bs:14bs:14
cÖavb cvwmi Drm †Kv_vq Aew¯’Z?
evwoi wfZ‡i…………………................01evwoi evB‡i……………………………..02Ab¨vb¨………….............................…...03
63
(wbw`©ó)cÖkœcÖkœ bs:15bs:15
Avcbvi evwo‡Z †Kvb ai‡bi Uq‡jU myweav Av‡Q?
gj‡kvabvkq/ AvaywbK cvqLvbv …………......01¯¨v‡ei cvqLvbv ……………………....….02M©Z Kiv cvqLvbv ………………………......Szjš— cvqLvbv ………………..…..…..04‡Lvjv cvqLvbv…………………….....….05‡Svc/gvV/DVvY…………………........06Ab¨vb¨………….............................…...07 (wbw`©ó)
cÖkœcÖkœ bs:16bs:16
Avcwb wK Ab¨ Avcwb wK Ab¨ M„n¯’jxi mv‡_ GB myweav¸‡jv Ask MÖnY K‡ib?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0022
Ask-4: wkïi ˆ`wnK e„w× gvcbc×wZ
cÖkcÖkœ œ bs:bs:
‡kªbx msL¨vevPK AsK GKKGKK
cÖkcÖkœ œ bs:bs:1717
D”PZv (‡m.wg)………………………………
.. (‡m.wg)
cÖkcÖkœ œ bs:bs:1818
ˆ`wnK IRb(‡K.wR)
………………………....
.. (‡K.wR)
cÖkcÖkœ œ bs:bs:1919
ga¨evûi cwiwa cwigvc (‡m.wg)(cm)……………………………………….
.. (‡m.wg)
Ask-5: wkïi LvIqv‡bvi c×wZ :
cÖkcÖkœ œ bs :bs :
cÖkœ ‡kªbx †Kv†KvWW
cÖkcÖkœ œ bs:bs:2020
Avcbvi ev”Pv‡K ey‡Ki `ya LvB‡qwQ‡jb wK?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖk Avcbvi ev”Pv‡K nu¨v
64
œ œ bs:bs:2121
kvj`ya LvB‡qwQ‡jb wK?
…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:bs:2222
Avcwb ev”Pv‡K R‡b¥i KZ¶Y ci ey‡Ki `ya LvIqv‡bv ïi“ K‡iwQ‡jb?
wgwbU .................................................................... N›Uv..............................................................................w`b.................................................................................. (wbw`©ó Ki“b)
cÖkcÖkœ œ bs:bs:2323
R‡b¥i ci ciB ev”Pv‡K gay, cvwb, wPwbi cvwb, wgQwii cvwb LvB‡qwQ‡jb wK?
nu¨v…........................................................01bv.............................................................02
cÖkcÖkœ œ bs:bs:2424
ev”Pv KZ gvm eqm ch©šZ ey‡Ki `ya †L‡q‡Q?
w`b..................................................................................................gvmgvm..................................................................................................eQieQi...................................................................................................... (wbw`©ó Ki“b)
cÖkcÖkœ œ bs:bs:2525
Avcbvi ev”Pvi Rb¨ Avcbvi ev”Pvi Rb¨ Avjv`v cvÎ Av‡Q wKAvjv`v cvÎ Av‡Q wK?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:bs:2626
wK ai‡bi cvÎ Avcbvi wK ai‡bi cvÎ Avcbvi wkï‡K LvIqv‡bvi Rb¨ wkï‡K LvIqv‡bvi Rb¨ e¨envi K‡ibe¨envi K‡ib?
‡evZj‡evZj ………………...........................01_vjv/ evwU_vjv/ evwU …………………...................02Kuv‡Pi †c†cUU …………………..................03Av‡_©b ‡ewmbAv‡_©b ‡ewmb ………………...................04wU‡bi †cwU‡bi †c--UU……………………................05ccvw÷‡Ki †cvw÷‡Ki †cUU …………………...............06w÷‡ji †cw÷‡ji †cUU ……………………..............07Ab¨vb¨Ab¨vb¨…………………………….........08 (wbw`©ó Ki“b)
cÖkcÖkœ œ bs:bs:2727
‡Kvb ai‡bi jeY Avcwb ‡Kvb ai‡bi jeY Avcwb LvIqvi Rb¨ e¨envi K‡ibLvIqvi Rb¨ e¨envi K‡ib ??
c¨v‡K‡Ui (Av‡qvwWbhy³)c¨v‡K‡Ui (Av‡qvwWbhy³) jeY jeY ..........................................................................................................0101‡Lvjv (‡Lvjv (Av‡qvwWbwenxbAv‡qvwWbwenxb) ) jeY.jeY.......................................................0202
cÖkcÖkœ œ bs:bs:2828
Avcwb wK we‡klfv‡e ev”Pvi Rb¨ Lvevi ˆZix ev”Pvi Rb¨ Lvevi ˆZix K‡ibK‡ib?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:bs:2929
Avcwb wK ‡ewk ‡Zj ev”Pvi Lvevi ˆZix‡Z ev”Pvi Lvevi ˆZix‡Z e¨envi K‡ibe¨envi K‡ib?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:bs:
Avcwb wK wLPzwi ˆZix Ki‡Z Rv‡bbˆZix Ki‡Z Rv‡bb?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................
65
3030 0202cÖkcÖkœ œ bs:bs:3131
KZevi Avcwb ev”Pvi ev”Pvi Rb¨ Rb¨ wLPzwi ˆZix ˆZix K‡i‡Qb?K‡i‡Qb?
1 evi………..........................................012 evi………..........................................023 evi………..........................................03Ab¨vb¨Ab¨vb¨…………………………….........04 (wbw`©ó Ki“b)
cÖkcÖkœ œ bs:bs:3232
KZevi Avcbvi ev”Pv ev”Pv wLPzwi ‡L‡q‡Q ‡L‡q‡Q GKw`‡b?GKw`‡b?
1 evi………..........................................012 evi………..........................................023 evi………..........................................03Ab¨vb¨Ab¨vb¨…………………………….........04 (wbw`©ó Ki“b)
Ask-6: mZ©KZvi c×wZ :
cÖkcÖkœ œ bs :bs :
cÖkœ ‡kªbx †Kv†KvWW
cÖkcÖkœ œ bs:3bs:333
Avcbvi ev”Pvi cÖavY ev”Pvi cÖavY ZZ¡veavqY †K K‡ib?ZZ¡veavqY †K K‡ib?
gv........................................................01ZZ¡veavqKZZ¡veavqK...................................….........02Ab¨vb¨Ab¨vb¨…………………………….........03 (wbw`©ó Ki“b)
cÖkcÖkœ œ bs:3bs:344 Avcbvi ev”Pv KZev”Pv KZ¶Y
Nygvq?
6-8N›Uv..................................................018-10N›Uv................................................02Ab¨vb¨Ab¨vb¨…………………………….........03 (wbw`©ó Ki“b)
cÖkcÖkœ œ bs:3bs:355
Avcwb wK K‡ib hLb Avcbvi ev”Pv †L‡Z bvev”Pv †L‡Z bv Pvq?Pvq?
ev”Pvi mv‡_ ev”Pvi mv‡_ †L‡j†L‡j..................................................................................0101Mvb †M‡q...................................................02Mí K‡i.......…..........................................03BwZnvm c‡o...............................................04Ab¨vb¨Ab¨vb¨……………………………..........
66
.05 (wbw`©ó Ki“b)
cÖkcÖkœ œ bs:3bs:366
Avcwb wK ev”Pvi ev”Pvi mv‡_ mv‡_ Mí K‡ib?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:3bs:377
Avcwb wK ev”Pv‡Kev”Pv‡K ‡Lj‡Z Drmvn K‡ib?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:3bs:388
Avcwb wK ev”Pvi ev”Pvi mv‡_ †L‡jb?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:3bs:399
Avcbvi ev”Pv Kvi ev”Pv Kvi mv‡_ †L‡j?mv‡_ †L‡j?
gv..............................................................01evev...........................................................02fvB............................................................03KvwRb........................................................04ZZ¡veavqKZZ¡veavqK …..............................................05`v`v/`v`x....................................................06Ab¨vb¨Ab¨vb¨……………………………...........07 (wbw`©ó Ki“b)
cÖkcÖkœ œ bs:4bs:400
Avcwb wK ev”Pv‡Kev”Pv‡K evB‡i wb‡q hvb?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:4bs:411
Avcbvi ev”Pv N‡i ev”Pv N‡i RyZv e¨envi K‡i?RyZv e¨envi K‡i?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:4bs:422
Avcbvi ev”Pv w`‡b ev”Pv w`‡b `yBevi `uvZ eªvk K‡i?`yBevi `uvZ eªvk K‡i?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:4bs:433
Avcwb wK ev”Pvi bL cªwZ mßv‡n Kvu‡Um?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:4bs:444
Avcwb wK ev”Pv‡K cÖwZ mßv‡n †Mvmj Kivb?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ
Avcwb wK ¯^v¯’¨ welq mg©_Y K‡ib?
nu¨v…........................................................…........................................................0101
67
bs:4bs:455
bv..........................................................................................................................0202
cÖkcÖkœ œ bs:4bs:466
Avcbvi ev”Pvi wbR¯^ _vjv Ges M-vm Av‡Q?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:4bs:477
Avcbvi ev”Pv ‡jLvcovi e¨vcv‡i wK K‡i?
KweZv….............................................…..01Mí..............................................……….02A½-cÖZ½……….......................................03MYbv…................................................….04AsK……….............................................05AsKY…….....................................…......06cwi‡e†ki Ecv`vb wkLv...................…..........07Ab¨vb¨Ab¨vb¨……………………………...........08 (wbw`©ó Ki“b)
Ask-7: ‡ivM wbqš¿b Kiv :
cÖkcÖkœ œ bs :bs :
cÖkœ ‡kªbx †Kv†KvWW
cÖkcÖkœ œ bs:4bs:488
Avcbvi ev”Pv‡K wK cÖ_g QqUv f¨vKwmb w`‡qwQ‡jb?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:4bs:499
Avcbvi ev”Pv‡K wK †cvwjI f¨vKwmb w`‡qwQ‡jb?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:5bs:500
Avcbvi ev”Pv wK MZ 15 w`‡b Amy¯’ n‡qwQj?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:5bs:511
hw` n¨uv nq ,Zvn‡j †Kvb ai‡bi?
R¡i….......................................................01Kvuwk /VvÛv….............................................02Wvqwiqv/cvZjv cvqLvbv…….........................03
68
ewg….......................................................04wbD‡gvwbqv……….....................................05Kv‡b¶Z …...............................................06P©g †ivM….................................................07dzmdzm mgm¨v….................................….....08Ab¨vb¨Ab¨vb¨……………………………...........09 (wbw`©ó Ki“b)
cÖkcÖkœ œ bs:5bs:522
Avcbvi ev”Pv KZw`b Wv³v‡ii Kv‡Q wb‡qwQ‡jb hLb †m Amy¯’ n‡qwQj?
w`b msL¨v…………………………..............(wbw`©ó Ki“b)
cÖkcÖkœ œ bs:5bs:533
Avcbvi ev”Pv wK ev”Pv wK mvevb e¨envi K‡i mvevb e¨envi K‡i Uq‡jU ‡_‡K Avmvi ci?Uq‡jU ‡_‡K Avmvi ci?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:5bs:544
Avcbvi ev”Pv wK ev”Pv wK mvevb e¨envi K‡I mvevb e¨envi K‡I Lvev‡ii c~©‡e?Lvev‡ii c~©‡e?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:5bs:555
Avcbvi ev”Pv AZx‡Z KZw`b Amy¯’ n‡qwQj?
w`b msL¨v…………………………..............(wbw`©ó Ki“b)
cÖkcÖkœ œ bs:5bs:566
Zvi wK GLbI †Kvb †ivM Av‡Q?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:5bs:577
hw` n¨uv nq ,Zvn‡j †Kvb ai‡bi?
R¡i….......................................................01Kvuwk /VvÛv….............................................02Wvqwiqv/cvZjv cvqLvbv…….........................03ewg….......................................................04wbD‡gvwbqv……….....................................05Kv‡b¶Z …...............................................06P©g †ivM….................................................07dzmdzm mgm¨v….................................….....08Ab¨vb¨Ab¨vb¨……………………………..........
69
.09 (wbw`©ó Ki“b)
cÖkcÖkœ œ bs:5bs:588
KZw`b †m Amy¯’ wQj?
w`b msL¨v…………………………..............(wbw`©ó Ki“b)
cÖkcÖkœ œ bs:5bs:599
†m wK GB Amy¯’Zvi Rb¨ nvmcvZv‡j wQj?
nu¨v…........................................................…........................................................0101bv..........................................................................................................................0202
cÖkcÖkœ œ bs:6bs:600
KZw`b †m nvmcvZv‡j wQj?
w`b msL¨v…………………………..............(wbw`©ó Ki“b)
Ask-8:Lvevi Mªn†bi ZvwjKv B›UviwfD kyi“I Av‡M:(24 N›Uv cybivq Lvevi c×wZ)
bs Lvev‡ii bvg cwigvY Kqevi †L‡q‡Q
01 fvZ (Kvc)
02 i“wU (UzKiv)
03 Wvj (Kvc)
04 gvsm/gvQ (UzKiv)
05 wWg (KqwU)
06 `ya (Kvc)
07 wLPzox (mvaviY)
08 wLPzox (Formulated cup)
09 kvK mewR (Kvc)
10 dj (KqwU)
11 nvjyqv/mywR/wdiwb (Kvc)
12 wPov/gywo (Kvc)
13 we¯‹zU14 wPwb/¸o (Pv-PvgP)
15 ‰Zj (Pv-PvgP)
16 Ab¨vb¨ (wbw`©ó Ki“b)
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INFORMATION TO INCLUDE IN ABSTRACT SUMMARY
The Committee will not consider any application, which does not include an abstract summary. The abstract should summarize the purpose of the study, the methods and procedures to be used, by addressing each of the following items. If an item is not applicable, please note accordingly:
1. Describe the requirements for a subject population and explain the rationale for using in this population special groups such as children, or groups whose ability to give voluntary informed consents may be in question.
2. Describe and assess any potential risks – physical, psychological, social, legal or other – and assess the likelihood and seriousness of such risks. If methods of research create potential risks, describe other methods, if any, that were considered and why they will not be used.
3. Describe procedures for protecting against or minimizing potential risks and an assessment of their likely effectiveness.
4. Include a description of the methods for safeguarding confidentiality or protecting anonymity.
5. When there are potential risks to the subject, or the privacy of the individual may be involved, the investigator is required to obtain a signed informed consent statement from the subject. For minors, informed consent must be obtained from the authorized legal guardian or parents of the subject. Describe consent procedures to be followed including how and where informed consent will be obtained.
a) If signed consent will not be obtained, explain why this requirement should be waived and provide an alternative procedure.
b) If information is to be withheld from a subject, justify this course of action.
c) If there is a potential risk to the subject or privacy of the individual is involved in any particular procedure include a statement in the consent form stating whether or not compensation and/or treatment will be available.
6. If study involves an interview, describe where and in what context the interview will take place. State approximate length of time required for the interview.
7. Assess the potential benefits to be gained by the individual subject as well as the benefits which may accrue to society in general as a result of the planned work. Indicate how the benefits outweigh the risks.
8. State if the activity requires the use of records (hospital, medical, birth, death or other), organs, tissues, body fluids, the fetus or the abortus.
The statement to the subject should include information specified in item 2,3,4,5(c) and 7 as well as indicating the approximate time required for participation in the activity.
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FORMAT FOR CONSENT FORMThe principles of informed consent and voluntary participation are cardinal elements to be observed throughout the research experiments, including its aftermath and applied use so that the research subjects are continually kept informed of any and all developments in so far as they affect them and others. However, without undermining the cardinal importance of obtaining informed consent in any way, from any human subjects involved in any research, the nature and form of the consent and the evidentiary requirements to prove that such consent was taken, shall depend upon the degree and seriousness of the invasiveness into the concerned subject’s person and privacy, health and life generally, and the overall purpose and importance of the research. Consent for participation in research is voluntary and informed only if it is given without any direct/indirect coercion and inducement, and is based on adequate briefing given to the participants about the details of the project. Keeping these principles, the following outlines are provided for designing the consent form.
Protocol Number: ________2009-002___________________________________________________
Protocol Title: _______________________________________________________________ A study on selected micronutrient intake of 2-4 years old children into lower socio economic
status (SES). _______________________________________________________________
Investigator’s name: Dr S. K. Roy
Organization :International Centre for Diarrhoeal Disease Research, Bangladesh
Introduction:
Micronutrients are active and potent in relatively tiny quantities, measured in milligrams or even
micrograms. Generally Micronutrients are vitamins and minerals that boost the nutritional value of
food. When a daily diet does not contain adequate levels of micronutrients, the outcome can have
dramatic consequences: children do not reach their full intellectual capacity, growth can be stunted,
and even blindness can occur. Most of the people of our country having lack of knowledge about
the micronutrients containing foods and therefore most of them are malnourished or micronutrients
deficient, specially the pregnant women and the infants are in the risk groups. Not only the lack of
knowledge also the differences between different socio-economic status, inadequate maternal and
72
child care due to inappropriate hygiene, health and nutrition are believed to be important factors for
inadequate intake of the selected micronutrients into the 2-4 years old children of our country.
Purpose of the research:
Micronutrients are the most important essential elements for the survival of the human being,
specially for the pregnant women and for the infants. Although micronutrient intake is varied
among the different Socio Economic Status (SES) in Bangladesh which cause the micronutrient
deficiency . To find out the daily intake of food satisfy the recommended level of selected
micronutrients among the 2-4 years old children or not. To fulfill this aspect this research is needed
and from this research we can determine the children of that specific group (2-4 years old) is
getting adequate amount of the selected micronutrients or not.Another purpose of this research is
to make the general people specially the rural people who are not very educated to be concerned
about the necessity of the intake of micronutrients daily in their food pattern.
Why selected ?
The rate of selected micronutrients intake into lower SES for the children aged 2-4 year is not
performed before. From this we can suggest what will be the correct food fortification is needed at
the present situation of Bangladesh for that particular group of the children. Micronutrients
deficiency causes a lot of diseases into lower SES and to solve this problem this research can be
helpful in various ways by providing a dietary chart for different SES.
What is expected from the patients/respondent?
Our expectation from that particular aged children’s mother or other family member will provide
the correct information about their baby’s daily diet and from which we can determine the current
selected micronutrients level .
What will be done to the participants?
73
If you are willing to participate, we will ask you some questions about baby’s health, and about
diets that you usually given to your baby. We will also measure your baby’s weight and height as
well as mid upper arm circumference. We estimate that completion of all these processes will take
around an hour.
Risk and benefits
There is no risk of our research because it is only a survey of selected micronutrients intake into 2-
4 years old children into lower socio economic status (SES). There is no risk from participating in
the study because we will not test any medicine and the study also does not involve any procedure
that could harm your baby.
Confidentiality
We will keep all of your and your baby’s information strictly confidential, and none other than the
staff of our study and the Ethical Review Committee of ICDDR,B that protects the interest of
research participants will have an access to your information. We would, however, like to tell you
that disclosure of such information is also guided by the law of Bangladesh. We will not use the
names or identities of you or your baby when we share the results with others and also in
publishing the findings of our study in medical journal.
Right not to participate and withdraw
Your and your baby’s participation in this study is absolutely voluntary i.e. you are the one to
decide for and against participation. You may also decide not to respond to any or all questions that
we ask you. You would also be able to withdraw your consent at any time during the study period.
Answering your questions
If you have any question regarding your baby’s health aspects, or about our study, you may ask us
now or in future. You will also be able to contact the principal investigator of this research study,
Dr. S.K Roy, at the Dhaka Hospital of ICDDR,B, Mohakhali, Dhaka-1212 personally or
communicate him over telephone 8860523-32 (extension number 2313)) or Mobile phone
No:01711849588. If you want to know more about your rights as a participant in a research study
74
or related issues you may contact Mr. M. A. Salam, Manager, Committee Coordination Office,
ICDDR,B, Mohakhali, Dhaka-1212 personally or communicate with him at the following
telephone number: 8860523-32 (extension number 3206) or direct: +880-2-9886495.
Principle of compensation
Payment for loss of earning of the study subjects may be considered in case the subjects require
extended hospitalization or confinement only for the purpose of the research and/or reimbursement
of cost of transportation for participating in the study. The amount should, however, be equivalent
to the loss and not so high that the offer might influence/bias judgment regarding participation in
the study.
The subjects shall also be provided free treatment for research related injuries.
Name, contact addresses and phone numbers of the PI as well as of the Committee Coordination
Secretariat should be provided in the consent form, in case participants have any query or want to
know about their rights and benefits.
If you agree to our proposal of enrolling you/your patient in our study, please indicate that by
putting your signature or your left thumb impression at the specified space below
Thank you for your cooperation
_______________________________________ ____________________Signature or left thumb impression of subject Date
_______________________________________ ____________________Signature or left thumb impression Dateof attendant/Guardian
_______________________________________ ____________________Signature or left thumb impression of the witness Date
_______________________________________ ___________________ Signature of the PI or his/her representative Date
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76
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Avgiv Avcbvi I Avcbvi wkïi me Z_¨ K‡Vvi fv‡e †Mvcb ivL‡ev | Avcbvi AbygwZ Qvov G M„nxZ Z_¨ Ethical Review Committee of ICDDR, B Qvov Ab¨ †Kvb RvqMvq cÖKvk Ki‡ev bv | Avgiv Avcbvi Ges Avcbvi wkïi bvg †Mvcb ivL‡ev ïay gvÎ Avcbvi AbygwZ mv‡c‡¶ Avgv‡`i M‡elbvq AskMÖnY Ki‡e |
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77
........................Awffve‡Ki ¯^v¶i ZvwiLt
78
Detailed Budget for the study titled: ______________13,698.00______________________________________________________________________
Name of Principal Investigator: _____Dr.S.K.Roy________________________Protocol Number: _____________Division: _____________________________Funding Source: _____________________________Budget: Director: US$____________; Indirect: US$__________; Total: US$__________Study period: From:_____________ through_______________Strategic Priority Code(s):
Line Items BudgetPayroll and Benefits: Name of personnel/position Pay level % Effort # of
postsMonthly
RateYear-1 Year-2 Year-3 Year-4 Year-5 Total amount
(US$)
Sub-total of Payroll and benefits:Travel and transport
Sub-total of Travel and Transport:Supply and materials
Sub-total of supply and materials:Other contractual
Sub-total of other contractual:Total direct costs:Total indirect cost:Total costs:
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