L-carnitine to Treat Fatigue Associated With Crohn's Disease
Study Details
Study Description
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 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 |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Carnitine Patients will take 4grams of L-carnitine (2 grams twice daily) for 3 months |
Drug: L-carnitine
dietary supplement
|
| 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. |
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).
|
Outcome Measures
Primary Outcome Measures
- Change in fatigue severity scale [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.
Secondary Outcome Measures
- Change in Multidimensional Fatigue Inventory [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients will have had previously macro- and microscopically verified Crohn's disease, as defined by traditional clinical and endoscopic standards.
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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).
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In addition, patients will need to answer "yes" to the screening study entry question ("Is fatigue a signficant problem for you currently?").
Exclusion Criteria:
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Exclusion criteria will include:
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age <18 or >70 years
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pregnancy or delivery within 6 months
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malignancy diagnosed within 1 year
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oral/intravenous steroid treatment within 6 months
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any surgery within 6 months
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presence of a stoma or ileo-anal J-pouch anastomosis
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concurrent hepatitis B or C infection
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cirrhosis
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renal insufficiency (CrCl<60) and history of seizure disorder or hypothyrodism.
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prior to study enrollment
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women of child-bearing age will need to undergo pregnancy testing.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCSF Medical Center, Mt. Zion Medical Center | San Francisco | California | United States | 94115 |
Sponsors and Collaborators
- University of California, San Francisco
Investigators
- Principal Investigator: Uma Mahadevan, MD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- carnitine and crohn's disease