Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

Phase 4

Completed

• Conditions: Low HDL-c; Spinal Cord Injury; High LDL-c; Tetraplegia; Quadraplegia
• Interventions: Dietary Supplement: Omega-3 supplements

• Registration Number: NCT01896037
• Lead Sponsor: University of Manitoba

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-05
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-11
• Primary Completion: 2017-01-28
• Study Completion: 2017-03-28
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Blood plasma levels of total cholesterol	Month 5	Change in blood plasma levels of total cholesterol at month 5 compared to baseline levels

Trial Locations

Locations (1)

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada