Clinical trial: vitamin D3 treatment in Crohn's disease - a randomized double-blind placebo-controlled study

被引:296
作者
Jorgensen, S. P. [1 ]
Agnholt, J. [1 ]
Glerup, H. [4 ]
Lyhne, S. [2 ]
Villadsen, G. E. [3 ]
Hvas, C. L. [1 ]
Bartels, L. E. [1 ]
Kelsen, J. [1 ]
Christensen, L. A. [1 ]
Dahlerup, J. F. [1 ]
机构
[1] Aarhus Univ Hosp, Dept Med Hepatol & Gastroenterol 5, DK-8000 Aarhus C, Denmark
[2] Randers Cent Hosp, Dept Med, DK-8900 Randers, Denmark
[3] Horsens Hosp, Dept Med, DK-8700 Horsens, Denmark
[4] Silkeborg Hosp, Dept Med, DK-8600 Silkeborg, Denmark
关键词
INFLAMMATORY-BOWEL-DISEASE; BONE-MINERAL DENSITY; CD4(+) T-CELLS;
D O I
10.1111/j.1365-2036.2010.04355.x
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
P>Background Vitamin D has immune-regulatory functions in experimental colitis, and low vitamin D levels are present in Crohn's disease. Aim To assess the effectiveness of vitamin D3 treatment in Crohn's disease with regard to improved disease course. Methods We performed a randomized double-blind placebo-controlled trial to assess the benefits of oral vitamin D3 treatment in Crohn's disease. We included 108 patients with Crohn's disease in remission, of which fourteen were excluded later. Patients were randomized to receive either 1200 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 1200 IU daily increased serum 25OHD from mean 69 nmol/L [standard deviation (s.d.) 31 nmol/L] to mean 96 nmol/L (s.d. 27 nmol/L) after 3 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). Conclusions Oral supplementation with 1200 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 Crohn's disease, we suggest larger studies to elucidate this matter further. ClinicalTrial.gov(NCT00122184).
引用
收藏
页码:377 / 383
页数:7
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