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Effects of Fish Oil and Colesevelam (STAIR7007)

Sponsor
University of Manitoba (Other)
Overall Status
Unknown status
CT.gov ID
NCT01948648
Collaborator
(none)
13
Enrollment
1
Location
3
Arms
41.7
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Colesevelam
  • Dietary Supplement: Fish Oil
  • Drug: Combination of fish oil and colesevelam
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Effects of Fish Oil, Colesevelam and Combination Therapy on Sterol Metabolism in Sitosterolemia
Actual Study Start Date :
Feb 6, 2018
Anticipated Primary Completion Date :
Apr 30, 2021
Anticipated Study Completion Date :
Jul 30, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma plant sterol level [32 weeks]

      plasma plant sterol assessment using Gas Chromatography(GC)

    Secondary Outcome Measures

    1. Fatty acid [32 weeks]

      use of gas chromatography technique to measure fish oil intervention

    2. endothelial functions [32 weeks]

      use of EndoPAT 2000 system to assess endothelial function

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Richardson Center for Functional Foods and Nutraceuticals Winnipeg Manitoba Canada

    Sponsors and Collaborators

    • University of Manitoba

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Manitoba
    ClinicalTrials.gov Identifier:
    NCT01948648
    Other Study ID Numbers:
    • B2013:075
    First Posted:
    Sep 23, 2013
    Last Update Posted:
    Nov 10, 2020
    Last Verified:
    Dec 1, 2019
    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
    Keywords provided by University of Manitoba
    plant sterols
    cholesterol
    colesevelam
    phytosterolemia
    fish oil
    Additional relevant MeSH terms:
    Colesevelam Hydrochloride

    Study Results

    No Results Posted as of Nov 10, 2020