This trial is active, not recruiting.

Condition sitosterolemia
Treatment ezetimibe
Sponsor University of Manitoba
Start date April 2012
End date August 2013
Trial size 8 participants
Trial identifier NCT01584206, B2011:051


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Compare on and off ezetimibe
10mg ezetimibe/day, at least 4 months

Primary Outcomes

Plasma cholesterol level
time frame: 8 months
Plasma sitosterol level
time frame: 8 months

Secondary Outcomes

Cholesterol absorption
time frame: 4 month
Cholesterol synthesis
time frame: 4 months

Eligibility Criteria

Male or female participants from 16 years up to 99 years old.

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

Additional Information

Official title Assessment of Sterol Metabolism in Sitosterolemia: A Pilot Study of Patients Treated With Ezetimibe
Principal investigator Semone B Myrie, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Manitoba.