Clinical trial: vitamin D3 treatment in Crohn's disease - a randomised double-blind placebo-controlled study.
Aliment Pharmacol Ther. 2010 May 11. Epub ahead of print
Jørgensen SP, Agnholt J, Glerup H, Lyhne S, Villadsen GE, Hvas CL, Bartels LE, Kelsen J, Christensen LA, Dahlerup JF.
Department of Medicine V (Hepatology and Gastroenterology), Aarhus University Hospital, DK-8000 Aarhus C, Denmark.
Background: Vitamin D has immune-regulatory functions in experimental colitis, and low vitamin D levels are present in Crohn's disease (CD). Aim: To assess the effectiveness of vitamin D3 treatment in CD with regard to improved disease course.
Methods: We performed a randomised double-blind placebo-controlled trial to assess the benefits of oral vitamin D3 treatment in CD. We included 108 patients with CD in remission, of which fourteen later were excluded. Patients were randomised to receive either 1,200 IU vitamin D3 (n = 46) or placebo (n = 48) once daily during 12 months. The primary endpoint was clinical relapse.
Results: Oral vitamin D3 treatment with 1,200 IU daily increased serum 25-OH-vitamin D from mean 69 nmol/l (standard deviation (SD) 31 nmol/l) to mean 96 nmol/l (SD 27 nmol/l) after three months (p < 0.001). The relapse rate was lower among patients treated with vitamin D3 (6/46 or 13%) than among patients treated with placebo (14/48 or 29%), (p = 0.06).
Conclusion: Oral supplementation with 1,200 IE vitamin D3 significantly increased serum vitamin D levels and insignificantly reduced the risk of relapse from 29% to 13%, (p = 0.06). Given that vitamin D3 treatment might be effective in CD we suggest larger studies to further elucidate this matter. ClinicalTrial.gov(NCT00122184). PMID: 20491740
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