Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Manitoba
Sponsor:
Collaborator:
The Association of Rehabilitation Medicine in Manitoba
Information provided by (Responsible Party):
Dr. KEthan, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01896037
First received: July 5, 2013
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Omega-3 Supplementation to Increase HDL-c Levels in Those With Tetraplegia

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Blood plasma levels of HDL-cholesterol [ Time Frame: Month 5 ] [ Designated as safety issue: No ]
    Change in blood plasma levels of HDL-cholesterol at month 5 compared to baseline levels


Secondary Outcome Measures:
  • Blood plasma levels of total cholesterol [ Time Frame: Month 5 ] [ Designated as safety issue: No ]
    Change in blood plasma levels of total cholesterol at month 5 compared to baseline levels


Estimated Enrollment: 30
Study Start Date: July 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • Previously having a heart attack or stroke
  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: NCT01896037

Contacts
Contact: Jessie Shea, MSc +1204 787-4619 jshea@hsc.mb.ca

Locations
Canada, Manitoba
Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada, R3A 1M4
Contact: Jessie Shea, MSc    +1204 787-4619    jshea@hsc.mb.ca   
Principal Investigator: Karen Ethans, MD         
Sponsors and Collaborators
University of Manitoba
The Association of Rehabilitation Medicine in Manitoba
Investigators
Principal Investigator: Karen Ethans, MD University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. KEthan, Director, Spinal Cord Rehabilitation Unit, University of Manitoba
ClinicalTrials.gov Identifier: NCT01896037     History of Changes
Other Study ID Numbers: HDL2013
Study First Received: July 5, 2013
Last Updated: April 8, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on August 21, 2014