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OpenTrials
Completed

NCT Number: NCT01584206

Sitosterolemia Metabolism

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.

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Key information

Conditions

Sitosterolemia

Age range

16 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ezetimibe

Drug

10mg ezetimibe/day, at least 4 months

Primary outcomes

  1. Plasma cholesterol level

    Time frame: 8 months

    Plasma cholesterol level will be assessed by GC

  2. Plasma sitosterol level

    Time frame: 8 months

    Plasma plant sterol assessment using GC

Secondary outcomes

  1. Cholesterol absorption

    Time frame: 4 month

    Use stable isotope technique to assess cholesterol absorption

  2. Cholesterol synthesis

    Time frame: 4 months

    Use of stable isotope to assess cholesterol synthesis.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

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

Acronym: STAIR7002

Important dates

Study start
2012
Primary completion
2013
Study completion
2016
First posted
Apr 24, 2012
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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