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.
|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|
- 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.
- 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.
|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)|
Active Comparator: Carnitine
Patients will take 4grams of L-carnitine (2 grams twice daily) for 3 months
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.
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523106
|United States, California|
|UCSF Medical Center, Mt. Zion Medical Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Uma Mahadevan, MD||University of California, San Francisco|