Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

NCT01896037 | Completed Phase 4

• 1 other identifier: HDL2013
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Blood plasma levels of HDL-cholesterol

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

  Month 5

Secondary Outcomes (1)

• Blood plasma levels of total cholesterol

  Month 5

Study Arms (1)

Omega-3 supplements

EXPERIMENTAL

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

Dietary Supplement: Omega-3 supplements

Interventions

Omega-3 supplements DIETARY_SUPPLEMENT

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

Omega-3 supplements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having chronic tetraplegia (at least on year since injury)
• years or older
• Having below normal fasting blood plasma levels of HDL-c (\<1 mmol/l)

You may not qualify if:

• Currently taking omega-3 supplements
• Currently taking medications for abnormal cholesterol
• Having a heart attack or stroke in the past one year

Sponsors & Collaborators

• University of Manitoba: lead
• The Association of Rehabilitation Medicine in Manitoba: collaborator

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A 1M4, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Ethans, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Spinal Cord Rehabilitation Unit

Study Record Dates

• First Submitted: July 5, 2013
• First Posted: July 11, 2013
• Study Start: July 1, 2013
• Primary Completion: January 28, 2017
• Study Completion: March 28, 2017
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

CA (1)