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Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

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ClinicalTrials.gov Identifier: NCT01896037
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : May 4, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
People with a spinal cord injury (SCI) characteristically have low levels of high-density lipoprotein-cholesterol (HDL-c; "good cholesterol") and high levels of low-density lipoprotein-cholesterol (LDL-c; "bad cholesterol"), and are at a higher risk of developing cardiovascular health problems, such as heart disease, heart attack and stroke, than the able-bodied population. A common way for able-bodied people to improve their lipid profile is through exercise; however, SCI people, especially tetraplegics, are often unable to achieve and maintain a level of exercise needed to obtain these benefits. It is therefore clinically important to find an effective, safe and inexpensive method of increasing HDL-c levels in people with chronic tetraplegia. This study will investigate the effects of omega-3 fatty acid supplementation on the lipid profile of people with tetraplegia. The investigators hypothesize that 5 months of daily consumption of high doses of omega-3 fatty acids will increase plasma levels of HDL-c in those with tetraplegia, leading to decreased risk of cardiovascular health issues.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Tetraplegia Quadraplegia Low HDL-c High LDL-c Dietary Supplement: Omega-3 supplements Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Omega-3 Supplementation to Increase HDL-c Levels in Those With Tetraplegia
Actual Study Start Date : July 2013
Primary Completion Date : January 28, 2017
Study Completion Date : March 28, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Omega-3 supplements
Daily omega-3 supplements of 600 mg EPA (Eicosapentaenoic acid) and 300 mg DHA (Docosahexaenoic acid) for 5 months.
Dietary Supplement: Omega-3 supplements
Daily omega-3 supplements of 600 mg EPA (Eicosapentaenoic acid) and 300 mg DHA (Docosahexaenoic acid) for 5 months.


Outcome Measures

Primary Outcome Measures :
  1. Blood plasma levels of HDL-cholesterol [ Time Frame: Month 5 ]
    Change in blood plasma levels of HDL-cholesterol at month 5 compared to baseline levels


Secondary Outcome Measures :
  1. Blood plasma levels of total cholesterol [ Time Frame: Month 5 ]
    Change in blood plasma levels of total cholesterol at month 5 compared to baseline levels


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having chronic tetraplegia (at least on year since injury)
  • 18 years or older
  • Having below normal fasting blood plasma levels of HDL-c (<1 mmol/l)

Exclusion Criteria:

  • Currently taking omega-3 supplements
  • Currently taking medications for abnormal cholesterol
  • Having a heart attack or stroke in the past one year
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896037


Locations
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1M4
Sponsors and Collaborators
University of Manitoba
The Association of Rehabilitation Medicine in Manitoba
Investigators
Principal Investigator: Karen Ethans, MD University of Manitoba
More Information

Responsible Party: Dr. Karen Ethans, Director, Spinal Cord Rehabilitation Unit, University of Manitoba
ClinicalTrials.gov Identifier: NCT01896037     History of Changes
Other Study ID Numbers: HDL2013
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by Dr. Karen Ethans, University of Manitoba:
Spinal cord injury
Tetraplegia
Quadraplegia
Cholesterol
HDL-c
LDL-c
Omega-3 fatty acids

Additional relevant MeSH terms:
Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms