The Effects of L-carnitine on Fatigue in Spinal Cord Injury
1 other identifier
interventional
2
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 29, 2010
CompletedFirst Posted
Study publicly available on registry
November 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedOctober 8, 2014
October 1, 2014
2.5 years
October 29, 2010
October 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fatigue Severity Scores (FSS) will be completed by subjects biweekly
starting from 3,4,5, or 6 weeks following initial visit, will continue throughout the 4 weeks of treatment and for 3 weeks following stop of treatment
Secondary Outcomes (3)
Fatigue VAS-F will be completed by subjects biweekly
starting from 3,4,5, or 6 weeks following initial visit, will continue throughout the 4 weeks of treatment and for 3 weeks following cessation of treatment
Pain VAS-P will be completed by subjects biweekly
starting from 3,4,5, or 6 weeks following initial visit, will continue throughout the 4 weeks of treatment and for 3 weeks following cessation of treatment
Depression CES-D will be completed by subjects biweekly
starting from 3,4,5, or 6 weeks following initial visit, will continue throughout the 4 weeks of treatment and for 3 weeks following cessation of treatment
Study Arms (1)
L-Carnitine
EXPERIMENTALThis study has a single subject design. Each subject acts as its own control. All subjects will go through intervention phase (treatment with L-Carnitine).
Interventions
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.
Eligibility Criteria
You may qualify if:
- Spinal Cord Injury: paraplegia or tetraplegia (ASIA A, B or C)
- More than 1 year since date of injury
- Clinically significant fatigue, determined by a score on the Fatigue Severity Scale greater than or equal to 4
- Between 19 and 65 years of age
- Ability to provide informed consent
You may not qualify if:
- Spinal Cord Injury ASIA D, or lack of Spinal Cord Injury
- Acute phase of rehabilitation: less than 1 year since date of injury
- Fatigue Severity Scale score less than 4
- Under 19 years of age or above 65 years of age
- Inability to provide informed consent
- Lack of proficiency in English, specified by an inability to read/understand consent form and complete tools
- Inability to come to GF Strong for 4 separate visits
- On-going treatment with anticoagulants such as warfarin or acenocoumarol
- Pregnancy, lactation or breast feeding
- History of seizures
- Hypothyroidism
- Severe liver or kidney disease
- Other on-going fatigue treatment over the past 6 months
- On-going treatment with L-carnitine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rehab Research Lab, GF Strong Rehab Centre, 4255 Laurel Street
Vancouver, British Columbia, V5Z 2G9, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Townson, MD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2010
First Posted
November 2, 2010
Study Start
October 1, 2010
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
October 8, 2014
Record last verified: 2014-10