search
Back to results

Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

Primary Purpose

Spinal Cord Injury, Tetraplegia, Quadraplegia

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Omega-3 supplements
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal cord injury, Tetraplegia, Quadraplegia, Cholesterol, HDL-c, LDL-c, Omega-3 fatty acids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omega-3 supplements

Arm Description

Daily omega-3 supplements of 600 mg EPA (Eicosapentaenoic acid) and 300 mg DHA (Docosahexaenoic acid) for 5 months.

Outcomes

Primary Outcome Measures

Blood plasma levels of HDL-cholesterol
Change in blood plasma levels of HDL-cholesterol at month 5 compared to baseline levels

Secondary Outcome Measures

Blood plasma levels of total cholesterol
Change in blood plasma levels of total cholesterol at month 5 compared to baseline levels

Full Information

First Posted
July 5, 2013
Last Updated
May 3, 2017
Sponsor
University of Manitoba
Collaborators
The Association of Rehabilitation Medicine in Manitoba
search

1. Study Identification

Unique Protocol Identification Number
NCT01896037
Brief Title
Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels
Official Title
Omega-3 Supplementation to Increase HDL-c Levels in Those With Tetraplegia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
January 28, 2017 (Actual)
Study Completion Date
March 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
The Association of Rehabilitation Medicine in Manitoba

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Tetraplegia, Quadraplegia, Low HDL-c, High LDL-c
Keywords
Spinal cord injury, Tetraplegia, Quadraplegia, Cholesterol, HDL-c, LDL-c, Omega-3 fatty acids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 supplements
Arm Type
Experimental
Arm Description
Daily omega-3 supplements of 600 mg EPA (Eicosapentaenoic acid) and 300 mg DHA (Docosahexaenoic acid) for 5 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 supplements
Intervention Description
Daily omega-3 supplements of 600 mg EPA (Eicosapentaenoic acid) and 300 mg DHA (Docosahexaenoic acid) for 5 months.
Primary Outcome Measure Information:
Title
Blood plasma levels of HDL-cholesterol
Description
Change in blood plasma levels of HDL-cholesterol at month 5 compared to baseline levels
Time Frame
Month 5
Secondary Outcome Measure Information:
Title
Blood plasma levels of total cholesterol
Description
Change in blood plasma levels of total cholesterol at month 5 compared to baseline levels
Time Frame
Month 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Ethans, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

We'll reach out to this number within 24 hrs