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Sitosterolemia Metabolism (STAIR7002)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Manitoba Identifier:
First received: April 16, 2012
Last updated: March 9, 2016
Last verified: December 2015
April 16, 2012
March 9, 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 Provided
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
Othman RA, Myrie SB, Mymin D, Merkens LS, Roullet JB, Steiner RD, Jones PJ. Ezetimibe reduces plant sterol accumulation and favorably increases platelet count in sitosterolemia. J Pediatr. 2015 Jan;166(1):125-31. doi: 10.1016/j.jpeds.2014.08.069. Epub 2014 Oct 16.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
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, Senior)
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