The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (The IBDVit Study): Double-Blind, Placebo-Controlled Trial of Adjuvant Vitamin D (Colecalciferol) With Corticosteroids in Active Crohn's Disease
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Clinical Remission (CDAI score <150)
研究概览
简要总结
The purpose of this study is to determine whether the addition of vitamin D to standard corticosteroids improves onset of remission in active Crohn's Disease, a form of Inflammatory Bowel Disease (IBD).
详细描述
Crohn's Disease is a form of Inflammatory Bowel Disease (IBD). It is caused by abnormal immune-mediated gut inflammation and is both chronic and difficult to treat. Symptoms are often unpleasant (e.g. abdominal pain, diarrhoea, disfiguring fistulation) and often lead to surgery to remove diseased bowel.
There is emerging evidence that Vitamin D, a nutrient largely produced in the skin upon exposure to sun-light, may possess properties regulating the immune system in IBD. In addition, vitamin D deficiency appears common in Inflammatory Bowel Disease.
This study aims to determine if the addition of vitamin D to standard corticosteroid treatment in active Crohn's Disease helps to achieve remission (resolution of symptoms).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Active Crohn's Disease Activity (CDAI) Score >200 to 450;
- •Diagnosis of IBD and distribution of disease previously confirmed
- •The participant able to give informed consent form;
- •Stable doses of the following concurrent IBD medications prior to inclusion:
- •5-aminosalicylates (≥4 weeks)
- •Thiopurines (≥8 weeks)
- •No corticosteroids (within 4 weeks)
- •No biological agents (within 8 weeks).
排除标准
- •Unable to give informed written consent;
- •Co-existence of any other chronic inflammatory conditions
- •Failure to meet concurrent IBD medication criteria;
- •Hypercalcaemia (Corrected serum calcium > 2.66 mmol/L) or history of vitamin D hypersensitivity;
- •Diagnosis of any of the flowing: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, nephrolithiasis, silicosis, liver failure, renal failure or malignancy, active TB, sarcoidosis or lymphoma or other granulomatous disease;
- •Known intolerance or contraindication to vitamin D or trial medication (i.e. corticosteroids / infliximab);
- •Biochemical disturbance at enrolment: serum corrected calcium > 2.66 mmol/L) or serum creatinine >250 micromol/L;
- •Pregnancy or breast-feeding.
研究组 & 干预措施
A
Standard corticosteroid treatment PLUS Vitamin D3 (Colecalciferol).
干预措施: Colecalciferol D3 (Vigantol Oil) (Drug)
B
Standard corticosteroid treatment PLUS placebo (Migliol Oil)
干预措施: Medium chain triglycerides (Drug)
结局指标
主要结局
Clinical Remission (CDAI score <150)
时间窗: 4 Weeks
次要结局
- Reduction in CDAI suggestive of a clinical improvement.(Week 4)
- Reduction in serum C-reactive protein.(Week 4)
- Reduction of faecal calprotectin levels(Week 4)
- Clinical Remission (CDAI score <150)(Week 6)