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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01232907
First received: October 29, 2010
Last updated: November 16, 2011
Last verified: November 2011
  Purpose
  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.


Condition Intervention Phase
Spinal Cord Injury (SCI)
Drug: L-Carnitine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of L-carnitine on Fatigue in Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Fatigue Severity Scores (FSS) will be completed by subjects biweekly [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fatigue VAS-F will be completed by subjects biweekly [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Pain VAS-P will be completed by subjects biweekly [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Depression CES-D will be completed by subjects biweekly [ Time Frame: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 4
Study Start Date: October 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L-Carnitine
This study has a single subject design. Each subject acts as its own control. All subjects will go through intervention phase (treatment with L-Carnitine).
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Lack of stability on pain or depression medication over the past 6 months, determined by history. The subjects will be asked about any changes in pain or depression medications over the past 6 months. If they have had a change in pain or depression medications or started a new pain or depression medication within the past 6 months, they will be excluded from the study. Subjects will be asked about their use of supplements and the indications for the supplements. Again, a change in supplements used for pain or depression in the past 6 months will result in exclusion from the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232907

Contacts
Contact: Bita Imam 604-714-4108 Bita.Imam@vch.ca

Locations
Canada, British Columbia
Rehab Research Lab, GF Strong Rehab Centre, 4255 Laurel Street Recruiting
Vancouver, British Columbia, Canada, V5Z 2G9
Sub-Investigator: William Miller         
Sub-Investigator: Hubert A. Anton         
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Andrea Townson, MD University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01232907     History of Changes
Other Study ID Numbers: H10-01570
Study First Received: October 29, 2010
Last Updated: November 16, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Spinal Cord Injury (SCI)

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014