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Trial record 29 of 51 for:    cord blood | ( Map: Canada )

Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

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

Tracking Information
First Submitted Date  ICMJE July 5, 2013
First Posted Date  ICMJE July 11, 2013
Last Update Posted Date May 4, 2017
Actual Study Start Date  ICMJE July 2013
Actual Primary Completion Date January 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injury
  • Tetraplegia
  • Quadraplegia
  • Low HDL-c
  • High LDL-c
Intervention  ICMJE 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2017)
21
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2013)
30
Actual Study Completion Date  ICMJE March 28, 2017
Actual Primary Completion Date January 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01896037
Other Study ID Numbers  ICMJE HDL2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Karen Ethans, University of Manitoba
Study Sponsor  ICMJE University of Manitoba
Collaborators  ICMJE The Association of Rehabilitation Medicine in Manitoba
Investigators  ICMJE
Principal Investigator: Karen Ethans, MD University of Manitoba
PRS Account University of Manitoba
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP