The Impact of Vitamin D on Disease Activity in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- The changes in disease activity on groups
研究概览
简要总结
The purpose for this study is to determine the effect of vitamin D supplementation on disease activity in Crohn's disease patients in Canada and Saudi Arabia
详细描述
Hypothesis 1: Patients who are suffering from Crohn's disease are at risk of vitamin D deficiency.
To determine vitamin D status and disease activity in Crohn's disease cases in Canada and Saudi Arabia.
Hypothesis 2: Providing vitamin D in doses higher than RDA (Recommended Dietary Allowance) reduces disease activity in Crohn's disease cases.
To evaluate the impact vitamin D in doses higher than RDA (Recommended Dietary Allowance) on disease activity in Crohn's disease 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosis with an active Crohn's disease,
- •age above of 16 years
排除标准
- •remission or the duration of disease is more than 2 years,
- •pregnancy,
- •liver or kidney failure,
- •inability to take oral supplements or medicine
研究组 & 干预措施
Group 1
Vitamin D3 600 IU daily (Control group, RDA level)
干预措施: Vitamin D3 (Dietary Supplement)
Group 3
Vitamin D3, 10,000 IU daily
干预措施: Vitamin D3 (Dietary Supplement)
Group 2
Vitamin D3 2,000 IU daily
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
The changes in disease activity on groups
时间窗: (0), 5 weeks, 9 weeks, after 2 months
We have 4 time points, baseline (0), Week 5, Week 9 (termination) and Week 17 (follow up) To measure the disease activity, we will examine C- reactive protein levels "blood test", Fecal fat " stool test" and Crohn's disease activity index (CDAI)"tool".
次要结局
- nutritional status(0, 5 weeks, 9 weeks, 2 months later)
- Health related quality of life((0), Week 5, Week 9 (termination) and 2 months later (follow up))
- vitamin D status((0), Week 5, Week 9 (termination) and 2 months later)
研究者
Hassanali Vatanparast
Associate Professor
University of Saskatchewan