L-carnitine to Treat Fatigue Associated With Crohn's Disease

• Status: Withdrawn
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco

Criteria

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.