Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

May 3, 2017 updated by: Dr. Karen Ethans, University of Manitoba

Omega-3 Supplementation to Increase HDL-c Levels in Those With Tetraplegia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M4
        • Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Month 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Month 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

The Association of Rehabilitation Medicine in Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2013

Primary Completion (ACTUAL)

January 28, 2017

Study Completion (ACTUAL)

March 28, 2017

Study Registration Dates

First Submitted

July 5, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (ESTIMATE)

July 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDL2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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