Effects of Fish Oil and Colesevelam (STAIR7007)

Not Applicable

• Conditions: Sitosterolemia
• Interventions: Drug: Colesevelam; Dietary Supplement: Fish Oil; Drug: Combination of fish oil and colesevelam

• Registration Number: NCT01948648
• Lead Sponsor: University of Manitoba

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 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.

Study Timeline

• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-23
• Study Start: 2018-02-06
• Status Verified: 2019-12
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-10
• Primary Completion: 2021-04-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. Confirmed diagnosis of homozygous sitosterolemia as established by genotyping and/or clinical parameters
2. Receiving ezetimibe treatment
3. Over 8 years of age (no maximum)
4. Concomitant illnesses or conditions

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Exclusion Criteria

1. Pregnancy
2. Intellectual disability
3. Bowel or biliary obstruction
4. Known hypersensitivity to colesevelam or any ingredients of colesevelam

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Colesevelam	Colesevelam	3.75g/day for 6 weeks
Fish Oil	Fish Oil	1g/day for 6 weeks
Combination of Fish Oil and Colesevelam	Combination of fish oil and colesevelam	3.75g/day of colesevelam and 1g/day of fish oil for 6 weeks

Primary Outcome Measures

Name	Time	Method
Plasma plant sterol level	32 weeks	plasma plant sterol assessment using Gas Chromatography(GC)

Secondary Outcome Measures

Name	Time	Method
endothelial functions	32 weeks	use of EndoPAT 2000 system to assess endothelial function
Fatty acid	32 weeks	use of gas chromatography technique to measure fish oil intervention

Trial Locations

Locations (1)

Richardson Center for Functional Foods and Nutraceuticals; 🇨🇦 Winnipeg, Manitoba, Canada