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Effects of Fish Oil and Colesevelam (STAIR7007)

NCT ID: NCT01948648

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-06

Study Completion Date

2021-07-30

Brief Summary

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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

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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

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Sitosterolemia

Keywords

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plant sterols cholesterol colesevelam phytosterolemia fish oil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Colesevelam

3.75g/day for 6 weeks

Group Type ACTIVE_COMPARATOR

Colesevelam

Intervention Type DRUG

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 Oil

1g/day for 6 weeks

Group Type ACTIVE_COMPARATOR

Fish Oil

Intervention Type DIETARY_SUPPLEMENT

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

Combination of Fish Oil and Colesevelam

3.75g/day of colesevelam and 1g/day of fish oil for 6 weeks

Group Type ACTIVE_COMPARATOR

Combination of fish oil and colesevelam

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Fish Oil

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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DRUG

Other Intervention Names

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Lodalis Omega-3 Omega-3 and Lodalis

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Richardson Center for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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B2013:075

Identifier Type: -

Identifier Source: org_study_id