Effects of Fish Oil and Colesevelam (STAIR7007)

November 6, 2020 updated by: University of Manitoba

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Richardson Center for Functional Foods and Nutraceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Colesevelam
3.75g/day for 6 weeks
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.
Other Names:
  • Lodalis
ACTIVE_COMPARATOR: Fish Oil
1g/day for 6 weeks
Dietary supplement: Fish Oil
In softgel form, contains 660mg EPA and 330mg DHA. Participant consume 1 softgel per day during treatment session.
Other Names:
  • Omega-3
ACTIVE_COMPARATOR: Combination of Fish Oil and Colesevelam
3.75g/day of colesevelam and 1g/day of fish oil for 6 weeks
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.
Other Names:
  • Omega-3 and Lodalis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma plant sterol level
Time Frame: 32 weeks
plasma plant sterol assessment using Gas Chromatography(GC)
32 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 6, 2018

Primary Completion (ANTICIPATED)

April 30, 2021

Study Completion (ANTICIPATED)

July 30, 2021

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 18, 2013

First Posted (ESTIMATE)

September 23, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2013:075

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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