Effects of Fish Oil and Colesevelam

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01948648
Recruitment Status : Not yet recruiting
First Posted : September 23, 2013
Last Update Posted : August 31, 2016
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 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
Study Start Date : October 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: Colesevelam
3.75g/day for 6 weeks
Drug: Colesevelam
Other Name: Lodalis
Active Comparator: Fish Oil
1g/day for 6 weeks
Dietary Supplement: Fish Oil
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
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

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
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 12 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

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

Responsible Party: University of Manitoba Identifier: NCT01948648     History of Changes
Other Study ID Numbers: B2013:075
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016

Keywords provided by University of Manitoba:
plant sterols
fish oil

Additional relevant MeSH terms:
Intestinal Diseases
Lipid Metabolism, Inborn Errors
Lipid Metabolism Disorders
Metabolic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents