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The Effects of L-carnitine on Fatigue in Spinal Cord Injury

NCT01232907 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2014-10-08

No results posted yet for this study

Summary

1. Purpose: To explore the use of L-Carnitine, a pharmaceutical product, for the treatment of fatigue in persons with spinal cord injury (SCI).
2. Hypothesis: Similar to previous research in disabled and aging populations, the investigators hypothesize that treatment with L-Carnitine will result in a significant improvement of clinical fatigue in spinal cord injury clients, effecting a decrease on the Fatigue Severity Scale (FSS) of 0.5 points or more. The investigators expect to see an effect after approximately three weeks of treatment.

As secondary outcomes, the investigators expect to see positive changes in the Centre for Epidemiologic Studies Depression Scale (CES-D)and Visual Analogue Fatigue (VAS-F) and Visual Analogue Pain (VAS-P) scores, due to a combination of previously demonstrated effects of L-Carnitine directly on pain and depression, and the effects of the potential decrease in fatigue.

Conditions

  • Spinal Cord Injury (SCI)

Interventions

DRUG

L-Carnitine

L-Carnitine, a pharmaceutical product, for the treatment of fatigue in persons with spinal cord injury will be used for this study. L-Carnitine is a nutrient normally obtained in the fat from meat. It promotes fatty acid oxidation of muscle, thereby promoting efficient energy production. Treatment with L-Carnitine has been shown to produce clinically significant improvement in fatigue in persons with multiple sclerosis (MS), cancer, and in aging populations. While the causes of fatigue in persons with SCI may be multifactorial, successful use of L-Carnitine in MS-related fatigue suggests it may have a role in SCI. Standard treatment will entail daily dosages of 1980 milligrams of L-Carnitine (three 330 mg tablets in the morning and three 330 mg tablets in the evening) for 4 weeks.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Andrea Townson, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01232907 on ClinicalTrials.gov