NCT01948648

Effects of Fish Oil and Colesevelam (STAIR7007)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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 description

Ezitimibe significantly lowers plant sterol levels in the blood of patients with sitosterolemia. However, plant sterol levels remain substantially elevated compared to those in healthy individuals. Thus, combination therapy needs to be considered. Agents that provide cardiovascular benefits such as colesevelam, a second-generation bile acid sequestrant, and fish oil are potential candidates to help further reduce sterol levels, but have yet to be evaluated in sitosterolemia patients. The purpose of this study is to dtermine the effects of colesevelam, fish oil and combination therapy (fish oil + colesevelam) on plant sterols, cholesterol and cardiovascular risk factors in sitosterolemia patients treated with ezetimibe. The results of this study will enhance knowledge on the pathogenesis of sitosterolemia and the mechanisim of actions of colesevelam and fish oil as adjunct therapies to ezitimibe in patients with the disease.

Conditions

• Sitosterolemia

Interventions

Type	Name	Description
DRUG	Colesevelam	Drug is in powder form, each packet contains 3.75g of colesevelam hydrochloride. Participant will mixed it with water and have 1 packet per day during the treatment session.
DIETARY_SUPPLEMENT	Fish Oil	In softgel form, contains 660mg EPA and 330mg DHA. Participant consume 1 softgel per day during treatment session.
DRUG	Combination of fish oil and colesevelam	combination of both colesevelam and fish oil. Participant will consume 1 packet and 1 softgel per day during treatment session.

Timeline

• Start date: 2018-02-06
• Primary completion: 2021-04-30
• Completion: 2021-07-30
• First posted: 2013-09-23
• Last updated: 2020-11-10

Locations

1 site across 1 country: Canada