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

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

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.

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.

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.