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OpenTrials
Completed

NCT Number: NCT01896037

Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases High LDL-C Low HDL-C Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadraplegia Quadriplegia Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Tetraplegia Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Health Sciences Centre

Winnipeg, Manitoba, R3A 1M4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 supplements

Dietary Supplement

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

Primary outcomes

  1. Blood plasma levels of HDL-cholesterol

    Time frame: Month 5

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

Secondary outcomes

  1. Blood plasma levels of total cholesterol

    Time frame: Month 5

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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • The Association of Rehabilitation Medicine in Manitoba

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2013
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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