Sitosterolemia Metabolism

Sitosterolemia Clinical Trial

— STAIR7002  

Official title:

Assessment of Sterol Metabolism in Sitosterolemia: A Pilot Study of Patients Treated With Ezetimibe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01584206
• Other study ID #: B2011:051
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2016
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Intestinal Diseases
• Lipid Metabolism, Inborn Errors
• Sitosterolemia

Intervention

Drug:
• Ezetimibe
10mg ezetimibe/day, at least 4 months

Locations

Country	Name	City	State
Canada	Richardson Centre for Functional Foods and Nutraceuticals	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma cholesterol level	Plasma cholesterol level will be assessed by GC	8 months
Primary	Plasma sitosterol level	Plasma plant sterol assessment using GC	8 months
Secondary	Cholesterol absorption	Use stable isotope technique to assess cholesterol absorption	4 month
Secondary	Cholesterol synthesis	Use of stable isotope to assess cholesterol synthesis.	4 months