L-carnitine to Treat Fatigue Associated With Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT01523106|
Recruitment Status : Withdrawn
First Posted : February 1, 2012
Last Update Posted : January 17, 2014
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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).
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): 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|