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Clinical trial: vitamin D3 treatment in Crohn's disease - a randomised double-blind placebo-controlled
study.
Jørgensen SP et al. Aliment Pharmacol Ther. 2010 May 11. [Epub ahead of print]
Page 1 Jørgensen SP et al. Aliment Pharmacol Ther. 2010 May 11
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Background
• Incidence of inflammatory bowel disease (IBD) such as Crohn’s disease is increasing.
• Incidence of IBD around most northern and southern latitudes is substantially higher than in latitudes nearer to equator. Increased incidence in northern and southern latitudes is connected to lack of sun light and thus, vitamin D.
• Deficit of vitamin D is common among patients with Crohn’s disease. This is due to worsened absorption of vitamin D from ileum and low intake.
• No controlled clinical studies have been conducted to determine the effect of vitamin D supplemention on disease activity in Crohn’s disease
Jørgensen SP et al. Aliment Pharmacol Ther. 2010 May 11
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Methods
• n=94 (randomized 50/50 to placebo and vitamin D)
• Vitamin D3 dose: 30 μg/day (1200 IU/day)
• Length: 52 weeks
• Drugs allowed atzatioprine (none were on biologic drugs)
• Primary outcomes: Clinical relapse rate at 1 year
• Secondary outcomes: serum 25-OH-vitamin D at month 3
3 Jørgensen SP et al. Aliment Pharmacol Ther. 2010 May 11
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Results
• Serum 25-OH-vitamin D inreased from 69 nmol/l (standard deviation (SD) 31 nmol/l) to mean 96 nmol/l (SD 27 nmol/l) after three months (p < 0.001)
4
( Δ p = 0.06)
14/48
Jørgensen SP et al. Aliment Pharmacol Ther. 2010 May 11
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Discussion
• Even if the difference between the groups did not become statistically significant, there was an absolute difference in number of relapses between the groups (6 vs 14 relapses, on vitamin D and placebo respectively)
• Results are intriguing, but large scale clinical studies are needed to confirm findings, preferably with higher dose of vitamin D
• Optimal vitamin D intake is essential for Crohn’s disease patients also from bone health perspective. Low vitamin D status predisposes to development of osteoporosis
5 Jørgensen SP et al. Aliment Pharmacol Ther. 2010 May 11
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Discussion
• Even if the difference between the groups did not become statistically significant, there was an absolute difference in number of relapses between the groups (6 vs 14 relapses, on vitamin D and placebo respectively)
• Results are intriguing, but large scale clinical studies are needed to confirm findings, preferably with higher dose of vitamin D
• Optimal vitamin D intake is essential for Crohn’s disease patients also from bone health perspective. Low vitamin D status predisposes to development of osteoporosis
5 Jørgensen SP et al. Aliment Pharmacol Ther. 2010 May 11
www.pronutritionist.net
