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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
dietary supplement
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).
UCSF Medical Center, Mt. Zion Medical Center
San Francisco, California, United States
Change in fatigue severity scale
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.
Time frame: From baseline to 3 months after intervention initiation
Change in Multidimensional Fatigue Inventory
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.
Time frame: From baseline to 3 months after intevention initiation
Change in handgrip strength
Handgrip strength will be assessed by a portable dynanometer. Maximal force after three tries will be recorded.
Time frame: From baseline to 3 months after treatment intervention
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