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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

January 18, 2012
May 15, 2013
August 2013
February 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01523106 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
L-carnitine to Treat Fatigue Associated With Crohn's Disease
L-carnitine to Treat Fatigue Associated With Crohn's Disease

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Crohn's Disease
  • Fatigue
  • Drug: L-carnitine
    dietary supplement
  • 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).
  • Active Comparator: Carnitine
    Patients will take 4grams of L-carnitine (2 grams twice daily) for 3 months
    Intervention: Drug: L-carnitine
  • 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.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
February 2014
February 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Not Provided
United States
 
NCT01523106
carnitine and crohn's disease
No
Uma Mahadevan, University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Uma Mahadevan, MD University of California, San Francisco
University of California, San Francisco
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP