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Trial record 3 of 13 for:    "sitosterolemia" OR "beta-sitosterolemia" OR "phytosterolaemia" OR "sitosterolaemia" OR "Mediterranean stomatocytosis macrothrombocytopenia"

Effects of Fish Oil and Colesevelam

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2016 by University of Manitoba
Information provided by (Responsible Party):
University of Manitoba Identifier:
First received: September 6, 2013
Last updated: August 30, 2016
Last verified: August 2016
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 Intervention
Drug: Colesevelam
Dietary Supplement: Fish Oil
Drug: Combination of fish oil and colesevelam

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effects of Fish Oil, Colesevelam and Combination Therapy on Sterol Metabolism in Sitosterolemia

Resource links provided by NLM:

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Plasma plant sterol level [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    plasma plant sterol assessment using Gas Chromatography(GC)

Secondary Outcome Measures:
  • Fatty acid [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    use of gas chromatography technique to measure fish oil intervention

  • endothelial functions [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    use of EndoPAT 2000 system to assess endothelial function

Estimated Enrollment: 16
Study Start Date: October 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01948648

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

Responsible Party: University of Manitoba Identifier: NCT01948648     History of Changes
Other Study ID Numbers: B2013:075 
Study First Received: September 6, 2013
Last Updated: August 30, 2016
Health Authority: Canada: Ethics Review Committee

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 processed this record on October 21, 2016