Status:
WITHDRAWN
L-carnitine to Treat Fatigue Associated With Crohn's Disease
Lead Sponsor:
University of California, San Francisco
Conditions:
Crohn's Disease
Fatigue
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 ...
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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01523106
Start Date
August 1 2013
End Date
February 1 2014
Last Update
January 17 2014
Active Locations (1)
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1
UCSF Medical Center, Mt. Zion Medical Center
San Francisco, California, United States, 94115