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

January 16, 2014 updated by: University of California, San Francisco

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • UCSF Medical Center, Mt. Zion Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Carnitine
Patients will take 4grams of L-carnitine (2 grams twice daily) for 3 months
Drug: L-carnitine
dietary supplement
Placebo Comparator: 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.
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fatigue severity scale
Time Frame: 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.
From baseline to 3 months after intervention initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Multidimensional Fatigue Inventory
Time Frame: 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.
From baseline to 3 months after intevention initiation
Change in handgrip strength
Time Frame: 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.
From baseline to 3 months after treatment intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Uma Mahadevan, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

January 28, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Estimate)

January 17, 2014

Last Update Submitted That Met QC Criteria

January 16, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • carnitine and crohn's disease

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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