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Effects of Fish Oil and Colesevelam

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ClinicalTrials.gov Identifier: NCT01948648
Recruitment Status : Not yet recruiting
First Posted : September 23, 2013
Last Update Posted : August 31, 2016
Sponsor:
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01948648


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

Responsible Party: University of Manitoba
ClinicalTrials.gov 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
cholesterol
colesevelam
phytosterolemia
fish oil

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