Clinical Trial: Effects of Fish Oil and Colesevelam

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effects of Fish Oil, Colesevelam and Combination Therapy on Sterol Metabolism in Sitosterolemia

Brief Summary: If treatment of colesevelam, fish oil in conjunction with ezetimibe, will lead to further reduction in plasma plant sterol levels in sitosterolemia patients. We hypothesize that treatments with fish oil, colesevelam and ezetimibe will maximize decrease in plasma concentrations of sitosterol and other plant sterols in sitosterolemia patients.

Detailed Summary:
Sponsor: University of Manitoba

Current Primary Outcome: Plasma plant sterol level [ Time Frame: 32 weeks ]

plasma plant sterol assessment using Gas Chromatography(GC)


Original Primary Outcome: Plasma plant sterol level [ Time Frame: 16 weeks ]

plasma plant sterol assessment using Gas Chromatography(GC)


Current Secondary Outcome:

  • Fatty acid [ Time Frame: 32 weeks ]
    use of gas chromatography technique to measure fish oil intervention
  • endothelial functions [ Time Frame: 32 weeks ]
    use of EndoPAT 2000 system to assess endothelial function


Original Secondary Outcome:

  • Cholesterol absorption [ Time Frame: 16 weeks ]
    use of stable isotope technique to assess cholesterol absorption
  • cholesterol synthesis [ Time Frame: 16 weeks ]
    use of stable isotope to assess cholesterol synthesis


Information By: University of Manitoba

Dates:
Date Received: September 6, 2013
Date Started: October 2016
Date Completion: December 2017
Last Updated: August 30, 2016
Last Verified: August 2016