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Sitosterolemia Metabolism (STAIR7002)

This study is currently recruiting participants.
Verified April 2012 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01584206
First received: April 16, 2012
Last updated: April 23, 2012
Last verified: April 2012
History of Changes
  Purpose

Ezetimibe has become the treatment choice for patients with sitosterolemia. Ezetimibe is an inhibitor of cholesterol absorption from the gastrointestinal tract. The purpose of this study is to determine if ezetimibe improves whole body plant sterol and cholesterol homeostasis.


Condition Intervention
Sitosterolemia
 Drug: Ezetimibe

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Assessment of Sterol Metabolism in Sitosterolemia: A Pilot Study of Patients Treated With Ezetimibe

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
Drug Information available for: Ezetimibe
U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Plasma cholesterol level [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    Plasma cholesterol level will be assessed by GC

  • Plasma sitosterol level [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    Plasma plant sterol assessment using GC


Secondary Outcome Measures:
  • Cholesterol absorption [ Time Frame: 4 month ] [ Designated as safety issue: No ]
    Use stable isotope technique to assess cholesterol absorption

  • Cholesterol synthesis [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Use of stable isotope to assess cholesterol synthesis.


Estimated Enrollment: 8
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ezetimibe
Compare on and off ezetimibe
 Drug: Ezetimibe
10mg ezetimibe/day, at least 4 months

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • confirmed diagnosis of homozygous sitosterolemia as established by genotyping and clinical parameters

Exclusion Criteria:

  • pregnant
  • intellectual disability
  • major infectious diseases
  • immunodeficiency
  • cancer
  • renal failure
  • diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584206

Contacts
Contact: Semone B Myrie, PhD 204-272-1555 myrie@cc.umanitoba.ca
Contact: Peter J Jones, PhD 204-474-8883 Peter_Jones@ad.umanitoba.ca

Locations
Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals Recruiting
Winnipeg, Manitoba, Canada, R3T 2N2
Principal Investigator: Semone B Myrie, PhD            
Principal Investigator: Peter J Jones, PhD            
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Semone B Myrie, PhD University of Manitoba
Study Chair: Peter J Jones, PhD University of Manitoba
  More Information

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01584206     History of Changes
Other Study ID Numbers: B2011:051
Study First Received: April 16, 2012
Last Updated: April 23, 2012
Health Authority: Canada: Ethics Review Committee
United States: Institutional Review Board

Keywords provided by University of Manitoba:
Sitosterolemia
Ezetimibe
Plant sterol
Cholesterol

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
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013