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

Not Applicable

Withdrawn

• Conditions: Crohn's Disease; Fatigue
• Interventions: Other: Placebo; Drug: L-carnitine

• Registration Number: NCT01523106
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-28
• Study First Posted: 2012-02-01
• Study Start: 2013-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-16
• Last Update Posted: 2014-01-17
• Primary Completion: 2014-02
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will take placebo for 3 months. Placebo is manufactured by the same company as the L-carnitine and will have a similar appearance.
Carnitine	L-carnitine	Patients will take 4grams of L-carnitine (2 grams twice daily) for 3 months

Primary Outcome Measures

Name	Time	Method
Change in fatigue severity scale	From baseline to 3 months after intervention initiation	The Fatigue Severity Score is a validated instrument to assess fatigue associated with chronic disease. The scale ranges from scores from 9 to 63, with a higher score indicated greater fatigue.

Secondary Outcome Measures

Name	Time	Method
Change in Multidimensional Fatigue Inventory	From baseline to 3 months after intevention initiation	This is a validated instrument to measure fatigue and has been validated for use for patients with inflammatory bowel disease. Scores range from 4-20, with higher scores indicated more severe fatigue.
Change in handgrip strength	From baseline to 3 months after treatment intervention	Handgrip strength will be assessed by a portable dynanometer. Maximal force after three tries will be recorded.

Trial Locations

Locations (1)

UCSF Medical Center, Mt. Zion Medical Center; 🇺🇸 San Francisco, California, United States