Sitosterolemia Metabolism

Not Applicable

Completed

• Conditions: Sitosterolemia
• Interventions: Drug: Ezetimibe

• Registration Number: NCT01584206
• Lead Sponsor: University of Manitoba

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Primary Completion: 2013-08
• Status Verified: 2015-12
• Study Completion: 2016-12
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ezetimibe	Ezetimibe	Compare on and off ezetimibe

Primary Outcome Measures

Name	Time	Method
Plasma cholesterol level	8 months	Plasma cholesterol level will be assessed by GC
Plasma sitosterol level	8 months	Plasma plant sterol assessment using GC

Secondary Outcome Measures

Name	Time	Method
Cholesterol synthesis	4 months	Use of stable isotope to assess cholesterol synthesis.
Cholesterol absorption	4 month	Use stable isotope technique to assess cholesterol absorption

Trial Locations

Locations (1)

Richardson Centre for Functional Foods and Nutraceuticals; 🇨🇦 Winnipeg, Manitoba, Canada