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

This study is not yet open for participant recruitment.
Verified May 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
Uma Mahadevan, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01523106
First received: January 18, 2012
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Crohn's Disease
Fatigue
 Drug: L-carnitine
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: L-carnitine to Treat Fatigue Associated With Crohn's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in fatigue severity scale [ Time Frame: From baseline to 3 months after intervention initiation ] [ Designated as safety issue: No ]
    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:
  • Change in Multidimensional Fatigue Inventory [ Time Frame: From baseline to 3 months after intevention initiation ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to 3 months after treatment intervention ] [ Designated as safety issue: No ]
    Handgrip strength will be assessed by a portable dynanometer. Maximal force after three tries will be recorded.


Estimated Enrollment: 200
Study Start Date: August 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523106

Locations
United States, California
UCSF Medical Center, Mt. Zion Medical Center Not yet recruiting
San Francisco, California, United States, 94115
Contact: Caroline Hwang, MD     415-502-4444     caroline.hwang@ucsf.edu    
Principal Investigator: Uma Mahadevan, MD            
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Uma Mahadevan, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Uma Mahadevan, Associate Professor of Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01523106     History of Changes
Other Study ID Numbers: carnitine and crohn's disease
Study First Received: January 18, 2012
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Crohn's disease
carnitine

Additional relevant MeSH terms:
Crohn Disease
Fatigue
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Signs and Symptoms
 Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013