NCT00152841终止2 期
Effect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease (IBD)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- calprotectin in stools at baseline, week 4, week 6, week 10
研究概览
简要总结
Hypothesis:In patients with ulcerative colitis and Crohn's disease diagnosed with mild or moderate anaemia:
- iron supplementation will increase disease activity and oxidative stress
- the addition of antioxidant vitamin will reduce this detrimental effect
详细描述
To maintain site/extent of disease and medication consistent among groups, the design is a double blind crossover placebo-controlled trial.
- If mild anaemia, patients are randomized to 300 mg of ferrous fumarate or placebo for 4 weeks followed by 2 weeks of washout period after which patients will crossover the opposite treatments for another 4 weeks.
- If moderate anaemia, patients will receive 600 mg of ferrous fumarate for 10 weeks. They are randomized to either vitamin E (800 IU) or placebo for 4 weeks followed by 2 weeks of washout period after which patients will crossover the opposite treatments for another 4 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •> 18 years old
- •diagnosed with inflammatory Bowel Disease (ulcerative colitis and Crohn's disease)
- •with mild or moderate anaemia
排除标准
- •not diagnosed with bowel obstruction
- •not diagnosed with short bowel syndrome
- •not taking iron supplement or antioxidant vitamins and minerals
结局指标
主要结局
calprotectin in stools at baseline, week 4, week 6, week 10
次要结局
- disease activity index
- oxidative stress (plasma lipid peroxides, antioxidant potency, vitamin C, vitamin E, superoxide dismutase)
- blood measurement of CBD
- iron status
研究者
研究点 (2)
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