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Effects of Fish Oil and Colesevelam (STAIR7007)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01948648
Recruitment Status : Active, not recruiting
First Posted : September 23, 2013
Last Update Posted : January 31, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sitosterolemia Drug: Colesevelam Dietary Supplement: Fish Oil Drug: Combination of fish oil and colesevelam Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : February 6, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

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 Name: 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 Name: 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 Name: Omega-3 and Lodalis

Primary Outcome Measures :
  1. Plasma plant sterol level [ Time Frame: 32 weeks ]
    plasma plant sterol assessment using Gas Chromatography(GC)

Secondary Outcome Measures :
  1. Fatty acid [ Time Frame: 32 weeks ]
    use of gas chromatography technique to measure fish oil intervention

  2. endothelial functions [ Time Frame: 32 weeks ]
    use of EndoPAT 2000 system to assess endothelial function

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01948648

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Canada, Manitoba
Richardson Center for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba

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Responsible Party: University of Manitoba Identifier: NCT01948648    
Other Study ID Numbers: B2013:075
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: December 2019

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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
fish oil
Additional relevant MeSH terms:
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Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents