Supplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- vitamin D3 supplementation in IBD patients with hypovitaminosis D.
研究概览
简要总结
This study aims to evaluate the effect of vitamin D3 supplementation on disease activity and quality of life in IBD patients deficient in vitamin D, and also help determine the optimal dose of vitamin D3 for them.
Hypothesis: Supplementation of vitamin D3 in IBD patients with hypovitaminosis D can improve their quality of life and decrease IBD activity.
详细描述
The incidence of hypovitaminosis D has been reported to be as high as 75% in patients with IBD. However, it is unclear whether low vitamin D levels contribute to the pathogenesis of IBD or are a consequence of IBD. Recent animal data studies suggest that maintenance of the epithelial barrier integrity in the large intestine by vitamin D is important in preventing IBD.
However, more evidence is required to determine the effect of vitamin D3 supplementation in patients with IBD. Furthermore, there is no clear consensus regarding the appropriate dose of vitamin D supplementation in IBD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- •18 years of age or older
- •25(OH)D levels <30ng/ml
- •willing to give informed written consent
排除标准
- •Age < 18 years
- •Women who are pregnant or planning to become pregnant
- •Patients already taking vitamin D3 ≥2,000 IU/daily prior to study enrollment
结局指标
主要结局
vitamin D3 supplementation in IBD patients with hypovitaminosis D.
时间窗: 90 days after patient taking the Vitamin D3 supplement daily
To determine the appropriate dose of vitamin D3 supplementation in IBD patients with hypovitaminosis D.
次要结局
- vitamin D3 supplementation on disease activity and quality of life(90 days after patient taking the Vitamin D3 supplement daily)