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

University of California San Francisco (UCSF)

Status: Withdrawn

Conditions: Fatigue; Crohn's Disease

Treatments: Other: Placebo; Drug: L-carnitine

Study type: Interventional

Funder types: Other

Identifiers

NCT01523106

carnitine and crohn's disease

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Carnitine

Active Comparator group

Description:

Patients will take 4grams of L-carnitine (2 grams twice daily) for 3 months

Treatment:

Drug: L-carnitine

Placebo

Placebo Comparator group

Description:

Patients will take placebo for 3 months. Placebo is manufactured by the same company as the L-carnitine and will have a similar appearance.

Treatment:

Other: Placebo