Sitosterolemia Metabolism (STAIR7002)

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: NCT01584206
Recruitment Status : Unknown
Verified December 2015 by University of Manitoba.
Recruitment status was:  Active, not recruiting
First Posted : April 24, 2012
Last Update Posted : March 10, 2016
Information provided by (Responsible Party):
University of Manitoba

April 16, 2012
April 24, 2012
March 10, 2016
April 2012
August 2013   (Final data collection date for primary outcome measure)
  • Plasma cholesterol level [ Time Frame: 8 months ]
    Plasma cholesterol level will be assessed by GC
  • Plasma sitosterol level [ Time Frame: 8 months ]
    Plasma plant sterol assessment using GC
Same as current
Complete list of historical versions of study NCT01584206 on Archive Site
  • Cholesterol absorption [ Time Frame: 4 month ]
    Use stable isotope technique to assess cholesterol absorption
  • Cholesterol synthesis [ Time Frame: 4 months ]
    Use of stable isotope to assess cholesterol synthesis.
Same as current
Not Provided
Not Provided
Sitosterolemia Metabolism
Assessment of Sterol Metabolism in Sitosterolemia: A Pilot Study of Patients Treated With Ezetimibe
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.
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Drug: Ezetimibe
10mg ezetimibe/day, at least 4 months
Experimental: Ezetimibe
Compare on and off ezetimibe
Intervention: Drug: Ezetimibe

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2016
August 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years to 99 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
University of Manitoba
University of Manitoba
Not Provided
Principal Investigator: Semone B Myrie, PhD University of Manitoba
Study Chair: Peter J Jones, PhD University of Manitoba
University of Manitoba
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP