Double-Blind Randomized Prospective Trial of Treatment With Natural Beta Carotene Vs. Placebo for Patients With Crohn's Disease in Remission
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- CDAI score measured 3-monthly during treatment
研究概览
简要总结
Many inflammatory disorders in the body are linked to oxidative tissue damage. Anti-oxidants that are present in many natural food sources may provide protection from such damage.
Beta carotene is an anti-oxidant vitamin present in many fruits and vegetables. The algae Dunaliella is particularly rich in beta carotene.
In this prospective trial we want to investigate whether beta carotene from Dunaliella may prevent exacerbations of Crohn's disease.
详细描述
Patients with documented Crohn's disease who are at least 2 months in remission (CDAI<150) will be randomized to receive 60 mg beta carotene/day vs. placebo for 1 year.
The study medication will be taken in addition to regular treatment for Crohn's disease.
The protocol includes 5 visits (months 0, 3, 6, 9, 12). Each visit lasts 30-60 minutes and includes a brief interview, standard questionnaires, physical examination, and blood tests.
Exacerbation of Crohn's disease is defined as CDAI>150. The study hypothesis is that less patients treated with beta carotene will suffer an exacerbation than patients treated with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 17 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with documented Crohn's disease in remission (CDAI<150) for at least two months, age 17-75 years
排除标准
- •active Crohn's disease (CDAI>150), partial bowel obstruction, impending surgery, pregnancy, serious other diseases
结局指标
主要结局
CDAI score measured 3-monthly during treatment
次要结局
未报告次要终点