Thiamin Against Robust IBD Fatigue
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fatigue
研究概览
简要总结
Patients with Inflammatory Bowel Disease (IBD), disease in remission and chronic fatigue will receive oral Thiamine treatment for 4 weeks in a RCT, cross-over study.
详细描述
Patients with Inflammatory Bowel Disease (IBD), disease in remission and chronic fatigue will receive high dose oral Thiamine treatment for 4 weeks in a RCT, cross-over study.
After the high dose treatment period, participants will be randomized to 3 months treatment with Thiamine 300mg/day or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blinded
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
- •Inflammatory Bowel Disease
- •Disease in remission
- •Chronic fatigue
排除标准
- •Co-morbidity that can explain fatigue
- •Pregnancy
- •Non-compliance to the study procedures
- •Possible surgery in the study period
研究组 & 干预措施
Thiamin
Oral thiamine: 600 - 1800 mg/day in 4 weeks. Dose is depending on gender and age. Tablet contains 300 mg Thiamine each.
干预措施: Thiamine (Drug)
Placebo
Placebo: same number of tablets as in the active comparator arm, in 4 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Fatigue
时间窗: After 4 weeks active treatment
Change in levels of fatigue measured by the Inflammatory Bowel Disease Fatigue Scale (IBD-F). Section I of the scale measures the severity of fatigue on a scale from 0-20, where 20 is maximum fatigue. A change in IBD-F score of 3 points or more is regarded as a clinical relevant change.
次要结局
- Fatigue(Week 8, 12, 24, and 52)
- Health-Related Quality of Life(Week 4, 8, 12, 24, and 52)
- Disease specific Health-Related Quality of Life(Week 4, 8, 12, 24, and 52)