Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

• Sponsor: University of Manitoba (Other)
• Overall Status: Completed
• CT.gov ID: NCT01896037
• Collaborator: The Association of Rehabilitation Medicine in Manitoba (Other)
• Enrollment: 21
• Location: 1
• Arm: 1
• Actual Duration (Months): 44.9
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury; Tetraplegia; Quadraplegia; Low HDL-c; High LDL-c	Dietary Supplement: Omega-3 supplements	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Omega-3 Supplementation to Increase HDL-c Levels in Those With Tetraplegia
• Actual Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Jan 28, 2017
• Actual Study Completion Date: Mar 28, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Blood plasma levels of total cholesterol [Month 5]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health Sciences Centre	Winnipeg	Manitoba	Canada	R3A 1M4

Sponsors and Collaborators

• University of Manitoba
• The Association of Rehabilitation Medicine in Manitoba

Investigators

• Principal Investigator: Karen Ethans, MD, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Karen Ethans, Director, Spinal Cord Rehabilitation Unit, University of Manitoba
• ClinicalTrials.gov Identifier: NCT01896037
• Other Study ID Numbers: HDL2013
• First Posted: Jul 11, 2013
• Last Update Posted: May 4, 2017
• Last Verified: May 1, 2017

• Keywords provided by Dr. Karen Ethans, Director, Spinal Cord Rehabilitation Unit, University of Manitoba: Spinal cord injury; Tetraplegia; Quadraplegia; Cholesterol; HDL-c; LDL-c; Omega-3 fatty acids
• Additional relevant MeSH terms: Spinal Cord Injuries; Quadriplegia

Study Results

No Results Posted as of May 4, 2017