L-carnitine to Treat Fatigue Associated With Crohn's Disease
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 1/1/2014 |
| Start Date: | August 2013 |
| End Date: | February 2014 |
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.
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.
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.
significant difference in fatigue between the treatment and control groups.
Inclusion Criteria:
- 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?").
Exclusion Criteria:
- 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.
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