L-carnitine to Treat Fatigue Associated With Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in fatigue severity scale
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study, comparing the effect of L-carnitine vs placebo on fatigue among Crohn's disease patients.
The specific aim of this study is to determine if treatment with L-carnitine is more effective than placebo at decreasing fatigue severity scores, while accounting for disease activity and concomitant anemia, depression/anxiety and poor sleep quality.
详细描述
A total of 100 patients will be recruited, in order to be able ensure to detect a significant difference in fatigue between the treatment and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will have had previously macro- and microscopically verified Crohn's disease, as defined by traditional clinical and endoscopic standards.
- •To be included, patients need to have disease which is either in remission or is mild to moderate in severity, as defined by the Harvey-Bradshaw Index Score (HBI<16).
- •In addition, patients will need to answer "yes" to the screening study entry question ("Is fatigue a signficant problem for you currently?").
排除标准
- •Exclusion criteria will include:
- •age <18 or >70 years
- •pregnancy or delivery within 6 months
- •malignancy diagnosed within 1 year
- •oral/intravenous steroid treatment within 6 months
- •any surgery within 6 months
- •presence of a stoma or ileo-anal J-pouch anastomosis
- •concurrent hepatitis B or C infection
- •cirrhosis
- •renal insufficiency (CrCl<60) and history of seizure disorder or hypothyrodism.
- •prior to study enrollment
- •women of child-bearing age will need to undergo pregnancy testing.
研究组 & 干预措施
Carnitine
Patients will take 4grams of L-carnitine (2 grams twice daily) for 3 months
干预措施: L-carnitine (Drug)
Placebo
Patients will take placebo for 3 months. Placebo is manufactured by the same company as the L-carnitine and will have a similar appearance.
干预措施: Placebo (Other)
结局指标
主要结局
Change in fatigue severity scale
时间窗: From baseline to 3 months after intervention initiation
The Fatigue Severity Score is a validated instrument to assess fatigue associated with chronic disease. The scale ranges from scores from 9 to 63, with a higher score indicated greater fatigue.
次要结局
- Change in Multidimensional Fatigue Inventory(From baseline to 3 months after intevention initiation)
- Change in handgrip strength(From baseline to 3 months after treatment intervention)