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

NCT ID: NCT01523106

Last Updated: 2014-01-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-02-28

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.

Conditions

Crohn's Disease; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Carnitine

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

Group Type: ACTIVE_COMPARATOR

L-carnitine

Intervention Type: DRUG

dietary supplement

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Patients will receive placebo, which will be manufactured by the same supplier as L-carnitine and appears identical. Patients will take an equal number of pills (8 pills/day).

Interventions

L-carnitine

dietary supplement

Intervention Type: DRUG

Placebo

Patients will receive placebo, which will be manufactured by the same supplier as L-carnitine and appears identical. Patients will take an equal number of pills (8 pills/day).

Intervention Type: OTHER

Eligibility 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uma Mahadevan, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Medical Center, Mt. Zion Medical Center

San Francisco, California, United States

Countries

United States

Other Identifiers

carnitine and crohn's disease

Identifier Type: -

Identifier Source: org_study_id