L-carnitine to Treat Fatigue Associated With Crohn's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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L-carnitine to Treat Fatigue Associated With Crohn's Disease

Conditions
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Crohn's Disease, Fatigue

Intervention / Treatment
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* Drug: L-carnitine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carnitine<br>Patients will take 4grams of L-carnitine (2 grams twice daily) for 3 months | Drug: L-carnitine<br>* dietary supplement<br>|
| Placebo Comparator: Placebo<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline to 3 months after intervention initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | From baseline to 3 months after treatment intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, carnitine