Remission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation
试验速览
- 阶段
- 2 期
- 入组人数
- 110
- 试验地点
- 8
- 主要终点
- Relapse rate within 1 year treatment; CDAI>220
研究概览
简要总结
The purpose of this study is to examine whether vitamin D treatment is effective in Crohn's disease.
详细描述
Crohns Disease is an inflammatory disease of primarily the small intestine and colon.
In recent years scientists have hypothesized that low blood vitamin-D levels play a role in the development of autoimmune diseases, including Crohns disease. The purpose of this study is to examine whether vitamin-D is effective in keeping remission in inactive Crohns Disease (double blind placebo controlled trial). The patients who have active disease in the placebo group (reach primary endpoint), will in an open setting receive a higher single dose vitamin-D and the effect will be measured within 4 weeks.
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
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Crohn's disease
- •Inactive Crohn's disease for at least 4 weeks
- •Crohn's Disease Activity Index (CDAI) < 150
- •C-reactive protein within normal range
- •Serum albumin within normal range
排除标准
- •Hypercalcemia
- •Short bowel syndrome
- •Pregnancy
结局指标
主要结局
Relapse rate within 1 year treatment; CDAI>220
次要结局
未报告次要终点
