Clinical trial: vitamin D3 treatment in Crohn's disease - a randomized double-blind placebo-controlled study
Clinical trial: vitamin D3 treatment in Crohn's disease - a randomized double-blind placebo-controlled study
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DOI：
10.1111/j.1365-2036.2010.04355.x
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发表时间：
2010-08-01
影响因子：
7.6
通讯作者：
Dahlerup, J. F.
中科院分区：
文献类型：
--
作者：
Jorgensen, S. P.;Agnholt, J.;Dahlerup, J. F.
研究背景维生素D在实验性结肠炎中具有免疫调节功能，而克罗恩病患者体内维生素D水平较低。目的评估维生素D3治疗克罗恩病在改善病程方面的有效性。方法我们进行了一项随机双盲安慰剂对照试验，以评估口服维生素D3治疗克罗恩病的益处。我们纳入了108例缓解期克罗恩病患者，其中14例后来被排除。患者随机接受1200 IU维生素D3（n = 46）或安慰剂（n = 48），每日一次，为期12个月。结果口服维生素D3 1200 IU/d治疗可使血清25 OHD从平均69 nmol/L [标准差（s.d.）31 nmol/L]至平均值96 nmol/L（s.d. 27 nmol/L），与对照组比较差异有显著性（P < 0.001）。维生素D3治疗的患者复发率较低（6/46或13%），比安慰剂治疗的患者（14/48或29%），（P = 0.06）。结论口服补充1200 IE维生素D3显着增加血清维生素D水平，并不显着降低复发的风险从29%至13%，（P = 0.06）。鉴于维生素D3治疗克罗恩病可能有效，我们建议进行更大规模的研究以进一步阐明这一问题。ClinicalTrial.gov（NCT00122184）。
P>BackgroundVitamin D has immune-regulatory functions in experimental colitis, and low vitamin D levels are present in Crohn's disease.AimTo assess the effectiveness of vitamin D3 treatment in Crohn's disease with regard to improved disease course.MethodsWe 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.ResultsOral 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).ConclusionsOral 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).