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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01523106
Recruitment Status : Withdrawn
First Posted : February 1, 2012
Last Update Posted : January 17, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Fatigue Drug: L-carnitine Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: L-carnitine to Treat Fatigue Associated With Crohn's Disease
Study Start Date : August 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

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).

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01523106

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United States, California
UCSF Medical Center, Mt. Zion Medical Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Uma Mahadevan, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco Identifier: NCT01523106     History of Changes
Other Study ID Numbers: carnitine and crohn's disease
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: January 17, 2014
Last Verified: January 2014
Keywords provided by University of California, San Francisco:
Crohn's disease
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Signs and Symptoms