Sitosterolemia Metabolism

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01584206

Acronym

STAIR7002

Enrollment

Registered

2012-04-24

Start date

2012-04-30

Completion date

2016-12-31

Last updated

2020-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sitosterolemia

Keywords

Sitosterolemia, Ezetimibe, Plant sterol, Cholesterol

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.

Interventions

DRUGEzetimibe

10mg ezetimibe/day, at least 4 months

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 99 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Cholesterol absorption	4 month	Use stable isotope technique to assess cholesterol absorption
Cholesterol synthesis	4 months	Use of stable isotope to assess cholesterol synthesis.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026