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

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Crohn's Disease, Fatigue

In brief

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.

Key facts

Study ID

NCT01523106

Run by

University of California, San Francisco

People needed

0

Starts

2013-08-01

Expected to finish

2014-02-01

Last updated by the study team

2014-01-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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?").

You may not qualify if…

• 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.

Where it is running

• UCSF Medical Center, Mt. Zion Medical Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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