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Sitosterolemia Metabolism (STAIR7002)

Primary Purpose

Sitosterolemia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ezetimibe
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sitosterolemia focused on measuring Sitosterolemia, Ezetimibe, Plant sterol, Cholesterol

Eligibility Criteria

16 Years - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Richardson Centre for Functional Foods and Nutraceuticals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ezetimibe

Arm Description

Compare on and off ezetimibe

Outcomes

Primary Outcome Measures

Plasma cholesterol level
Plasma cholesterol level will be assessed by GC
Plasma sitosterol level
Plasma plant sterol assessment using GC

Secondary Outcome Measures

Cholesterol absorption
Use stable isotope technique to assess cholesterol absorption
Cholesterol synthesis
Use of stable isotope to assess cholesterol synthesis.

Full Information

First Posted
April 16, 2012
Last Updated
January 29, 2020
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT01584206
Brief Title
Sitosterolemia Metabolism
Acronym
STAIR7002
Official Title
Assessment of Sterol Metabolism in Sitosterolemia: A Pilot Study of Patients Treated With Ezetimibe
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sitosterolemia
Keywords
Sitosterolemia, Ezetimibe, Plant sterol, Cholesterol

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ezetimibe
Arm Type
Experimental
Arm Description
Compare on and off ezetimibe
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Intervention Description
10mg ezetimibe/day, at least 4 months
Primary Outcome Measure Information:
Title
Plasma cholesterol level
Description
Plasma cholesterol level will be assessed by GC
Time Frame
8 months
Title
Plasma sitosterol level
Description
Plasma plant sterol assessment using GC
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Cholesterol absorption
Description
Use stable isotope technique to assess cholesterol absorption
Time Frame
4 month
Title
Cholesterol synthesis
Description
Use of stable isotope to assess cholesterol synthesis.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Semone B Myrie, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter J Jones, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Study Chair
Facility Information:
Facility Name
Richardson Centre for Functional Foods and Nutraceuticals
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 2N2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28625503
Citation
Othman RA, Myrie SB, Mymin D, Roullet JB, DeBarber AE, Steiner RD, Jones PJH. Thyroid Hormone Status in Sitosterolemia Is Modified by Ezetimibe. J Pediatr. 2017 Sep;188:198-204.e1. doi: 10.1016/j.jpeds.2017.05.049. Epub 2017 Jun 16.
Results Reference
derived
PubMed Identifier
25444527
Citation
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.
Results Reference
derived

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Sitosterolemia Metabolism

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