Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Sitosterolemia Metabolism (STAIR7002)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01584206
First received: April 16, 2012
Last updated: December 17, 2014
Last verified: August 2013

April 16, 2012
December 17, 2014
April 2012
May 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01584206 on ClinicalTrials.gov Archive Site
  • 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.
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
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Sitosterolemia
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
8
May 2015
May 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
Both
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01584206
B2011:051
Yes
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
August 2013

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