Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

• ClinicalTrials.gov Identifier: NCT01896037
• Recruitment Status: Completed
• First Posted: July 11, 2013
• Last Update Posted: May 4, 2017
• Sponsor: University of Manitoba
• Collaborator: The Association of Rehabilitation Medicine in Manitoba
• Information provided by (Responsible Party): Dr. Karen Ethans, University of Manitoba

Tracking Information

• First Submitted Date: July 5, 2013
• First Posted Date: July 11, 2013
• Last Update Posted Date: May 4, 2017
• Actual Study Start Date: July 2013
• Actual Primary Completion Date: January 28, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 8, 2014)

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

Original Primary Outcome Measures (submitted: July 10, 2013)

Blood plasma levels of HDL-cholesterol [ Time Frame: Week 42 ]

Change in blood plasma levels of HDL-cholesterol at week 42 compared to baseline levels

• Change History: Complete list of historical versions of study NCT01896037 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: April 8, 2014)

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

Original Secondary Outcome Measures (submitted: July 10, 2013)

• Blood plasma levels of HDL-cholesterol [ Time Frame: Week 21 ]
  Change in blood plasma levels of HDL-cholesterol at week 21 compared to baseline levels
• Blood plasma levels of total cholesterol [ Time Frame: Week 21 ]
  Change in blood plasma levels of total cholesterol at week 21 compared to baseline levels
• Blood plasma levels of total cholesterol [ Time Frame: Week 42 ]
  Change in blood plasma levels of total cholesterol at week 42 compared to baseline levels

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels
• Official Title: Omega-3 Supplementation to Increase HDL-c Levels in Those With Tetraplegia
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

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.

Study Arms

Experimental: Omega-3 supplements

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

Intervention: Dietary Supplement: Omega-3 supplements

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 3, 2017): 21
• Original Estimated Enrollment (submitted: July 10, 2013): 30
• Actual Study Completion Date: March 28, 2017
• Actual Primary Completion Date: January 28, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01896037
• Other Study ID Numbers: HDL2013
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Karen Ethans, University of Manitoba
• Study Sponsor: University of Manitoba
• Collaborators: The Association of Rehabilitation Medicine in Manitoba

Investigators

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

• PRS Account: University of Manitoba
• Verification Date: May 2017