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Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

U

University of Manitoba

Status and phase

Completed
Phase 4

Conditions

Tetraplegia
High LDL-c
Quadraplegia
Spinal Cord Injury
Low HDL-c

Treatments

Dietary Supplement: Omega-3 supplements

Study type

Interventional

Funder types

Other

Identifiers

NCT01896037
HDL2013

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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