Effects of Fish Oil and Colesevelam (STAIR7007)

N/AUnknownNCT01948648

University of Manitoba13 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Sitosterolemia

Interventions

ColesevelamDRUG

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.

Fish OilDIETARY_SUPPLEMENT

In softgel form, contains 660mg EPA and 330mg DHA. Participant consume 1 softgel per day during treatment session.

Combination of fish oil and colesevelamDRUG

combination of both colesevelam and fish oil. Participant will consume 1 packet and 1 softgel per day during treatment session.

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

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

Locations (1)

Richardson Center for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

Plasma plant sterol level

plasma plant sterol assessment using Gas Chromatography(GC)

Time frame: 32 weeks

Secondary Outcomes

Fatty acid

use of gas chromatography technique to measure fish oil intervention

Time frame: 32 weeks

endothelial functions

use of EndoPAT 2000 system to assess endothelial function

Time frame: 32 weeks

Data from ClinicalTrials.gov

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