Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896037
• Other study ID #: HDL2013
• Status: Completed
• Phase: Phase 4
• First received: July 5, 2013
• Last updated: May 3, 2017
• Start date: July 2013
• Est. completion date: March 28, 2017

Study information

• Verified date: May 2017
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 28, 2017
• Est. primary completion date: January 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• High LDL-c
• Low HDL-c
• Quadraplegia
• Quadriplegia
• Spinal Cord Injuries
• Spinal Cord Injury
• Tetraplegia

Intervention

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

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	The Association of Rehabilitation Medicine in Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood plasma levels of HDL-cholesterol	Change in blood plasma levels of HDL-cholesterol at month 5 compared to baseline levels	Month 5
Secondary	Blood plasma levels of total cholesterol	Change in blood plasma levels of total cholesterol at month 5 compared to baseline levels	Month 5