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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carnitine | Active Comparator | Patients will take 4grams of L-carnitine (2 grams twice daily) for 3 months |
|
| Placebo | Placebo Comparator | Patients will take placebo for 3 months. Placebo is manufactured by the same company as the L-carnitine and will have a similar appearance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-carnitine | Drug | dietary supplement |
| |
| Placebo |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria will include:
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| Name | Affiliation | Role |
|---|---|---|
| Uma Mahadevan, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center, Mt. Zion Medical Center | San Francisco | California | 94115 | United States |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Other |
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). |
|
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 |
| D007410 | Intestinal Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |