Cholecalciferol Comedication in Patients With Chronic Inflammatory Bowel Diseases (Crohn's Disease or Ulcerative Colitis) - the 5C-study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- fecal calprotectin
研究概览
简要总结
Vitamin D deficiency (defined as 25(OH)-vitamin D serum level <50 nmol/ l) is associated with irritable bowel disease (IBD). National guidelines recommend the administration of 800 -4000 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Cumulative intermittent administration monthly or weekly is possible. The study aims to compare inflammation activity (primary outcome) after monthly or weekly treatment with soft capsules containing 24'000 IU cholecalciferol compared to no vitamin D supplementation. Quantification of 25(OH)-vitamin D serum values is a secondary outcome. The investigators will use newly developed soft capsules.
详细描述
Monthly supplementation: Monthly administration of a capsule containing 24'000 IU vitamin D, corresponding to a dose of approximately 800 IU per day, as comedication to the usual treatment during 6 months.
Weekly supplementation: Weekly administration of a capsule containing 24'000 IU vitamin D, corresponding a dose of approximately 3500 IU per day, as comedication to the usual treatment during 6 months.
Control: Usual treatment without vitamin D supplementation. All 3 groups: In a follow-up phase of 6 months, all participants can choose whether they want a monthly vitamin D supplementation or not.
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
- None
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
- •diagnosis of Crohn disease or ulcerative colitis
排除标准
- •hypercalcaemia
研究组 & 干预措施
weekly supplementation
Weekly administration of a capsule containing 24'000 IU vitamin D, corresponding to a dose of approximately 3500 IU per day, as comedication to the usual treatment during 6 months.
干预措施: Vitamin D3 (Drug)
monthly supplementation
Monthly administration of a capsule containing 24'000 IU vitamin D, corresponding to a dose of approximately 800 IU per day, as comedication to the usual treatment during 6 months.
干预措施: Vitamin D3 (Drug)
结局指标
主要结局
fecal calprotectin
时间窗: every 2 months during 6 months
laboratory disease activity
次要结局
- (OH)-vitamin D serum value(every 2 months during 6 months)