Inpharma 1627 - 1 Mar 2008 Supplements fail to improve development in Down’s syndrome There is evidence that Down’s syndrome (trisomy 21) and related abnormalities may be associated with oxidative stress and folate deficiency, note UK researchers, who therefore conducted a study assessing supplementation with antioxidants and folate in infants with Down’s syndrome. 1 However, they report that there was no evidence for any benefit with such treatment in this setting. The study involved 156 infants aged < 7 months with Down’s syndrome who were randomised to receive one of the following four daily oral treatments: antioxidants comprising selenium 10µg, zinc 5mg, retinol [vitamin A] 0.9mg, tocopherol [vitamin E] 100mg and ascorbic acid [vitamin C] 50mg; folinic acid [leucovorin] 0.1mg; antioxidants plus folinic acid; or placebo. Among infants evaluable for the primary outcome, which was the Griffiths developmental quotient, there were no significant differences with (n = 73) versus without (65) antioxidant treatment (mean difference 1.2 points; 95% CI –2.2, 4.6), or with (68) versus without (70) folinic acid treatment (mean difference 1.7 points; 95% CI –1.7, 5.1). Furthermore, there were no differences between treatments for development of language, as assessed by a modified MacArthur communicative development inventory, or for activity of the antioxidant enzymes (superoxide dismutase and glutathione peroxidase) that are affected by trisomy 21. In an accompanying editorial, chemical pathologist Tim Reynolds from Queen’s Hospital, Burton on Trent, UK comments that, as differences between fetuses with and without trisomy 21 are evident at as early as 10 weeks’ gestation, "postnatal supplementation would be unlikely to work", although he suggests that supplementation prior to conception could have a protective effect. 2 However, he concludes: "Giving vitamins to 6 month old babies with trisomy 21 does not improve their educational achievement, and . . . cannot be recommended." 1. Ellis JM, et al. Supplementation with antioxidants and folinic acid for children with Down’s syndrome: randomised controlled trial. BMJ 336: 594-597, No. 7644, 15 Mar 2008. 2. Reynolds T. Giving antioxidants to infants with Down’s syndrome: does not improve psychomotor development. BMJ 336: 568-569, No. 7644, 15 Mar 2008. 801099472 1 Inpharma 1 Mar 2008 No. 1627 1173-8324/10/1627-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Supplements fail to improve development in Down's syndrome

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Inpharma 1627 - 1 Mar 2008

Supplements fail to improvedevelopment in Down’s syndromeThere is evidence that Down’s syndrome (trisomy 21)

and related abnormalities may be associated withoxidative stress and folate deficiency, note UKresearchers, who therefore conducted a study assessingsupplementation with antioxidants and folate in infantswith Down’s syndrome.1 However, they report thatthere was no evidence for any benefit with suchtreatment in this setting.

The study involved 156 infants aged < 7 months withDown’s syndrome who were randomised to receive oneof the following four daily oral treatments: antioxidantscomprising selenium 10µg, zinc 5mg, retinol [vitamin A]0.9mg, tocopherol [vitamin E] 100mg and ascorbic acid[vitamin C] 50mg; folinic acid [leucovorin] 0.1mg;antioxidants plus folinic acid; or placebo.

Among infants evaluable for the primary outcome,which was the Griffiths developmental quotient, therewere no significant differences with (n = 73) versuswithout (65) antioxidant treatment (mean difference1.2 points; 95% CI –2.2, 4.6), or with (68) versuswithout (70) folinic acid treatment (mean difference1.7 points; 95% CI –1.7, 5.1). Furthermore, there wereno differences between treatments for development oflanguage, as assessed by a modified MacArthurcommunicative development inventory, or for activity ofthe antioxidant enzymes (superoxide dismutase andglutathione peroxidase) that are affected by trisomy 21.

In an accompanying editorial, chemical pathologistTim Reynolds from Queen’s Hospital, Burton on Trent,UK comments that, as differences between fetuses withand without trisomy 21 are evident at as early as10 weeks’ gestation, "postnatal supplementation wouldbe unlikely to work", although he suggests thatsupplementation prior to conception could have aprotective effect.2 However, he concludes: "Givingvitamins to 6 month old babies with trisomy 21 doesnot improve their educational achievement, and . . .cannot be recommended."1. Ellis JM, et al. Supplementation with antioxidants and folinic acid for children

with Down’s syndrome: randomised controlled trial. BMJ 336: 594-597, No.7644, 15 Mar 2008.

2. Reynolds T. Giving antioxidants to infants with Down’s syndrome: does notimprove psychomotor development. BMJ 336: 568-569, No. 7644, 15 Mar 2008.

801099472