Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

Study Overview
=================
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.

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

Conditions
-----------------
Spinal Cord Injury, Tetraplegia, Quadraplegia, Low HDL-c, High LDL-c

Intervention / Treatment
-----------------
* Dietary Supplement: Omega-3 supplements


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3 supplements<br>Daily omega-3 supplements of 600 mg EPA (Eicosapentaenoic acid) and 300 mg DHA (Docosahexaenoic acid) for 5 months. | Dietary Supplement: Omega-3 supplements<br>* Daily omega-3 supplements of 600 mg EPA (Eicosapentaenoic acid) and 300 mg DHA (Docosahexaenoic acid) for 5 months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood plasma levels of HDL-cholesterol | 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 | Change in blood plasma levels of total cholesterol at month 5 compared to baseline levels | Month 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal cord injury, Tetraplegia, Quadraplegia, Cholesterol, HDL-c, LDL-c, Omega-3 fatty acids