Sitosterolemia Metabolism

NCT ID: NCT01584206

Last Updated: 2020-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Sitosterolemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ezetimibe

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Group Type EXPERIMENTAL

Ezetimibe

Intervention Type DRUG

10mg ezetimibe/day, at least 4 months

Interventions

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Ezetimibe

10mg ezetimibe/day, at least 4 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Semone B Myrie, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Peter J Jones, PhD

Role: STUDY_CHAIR

University of Manitoba

Locations

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Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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Othman RA, Myrie SB, Mymin D, Roullet JB, DeBarber AE, Steiner RD, Jones PJH. Thyroid Hormone Status in Sitosterolemia Is Modified by Ezetimibe. J Pediatr. 2017 Sep;188:198-204.e1. doi: 10.1016/j.jpeds.2017.05.049. Epub 2017 Jun 16.

Reference Type DERIVED
PMID: 28625503 (View on PubMed)

Othman RA, Myrie SB, Mymin D, Merkens LS, Roullet JB, Steiner RD, Jones PJ. Ezetimibe reduces plant sterol accumulation and favorably increases platelet count in sitosterolemia. J Pediatr. 2015 Jan;166(1):125-31. doi: 10.1016/j.jpeds.2014.08.069. Epub 2014 Oct 16.

Reference Type DERIVED
PMID: 25444527 (View on PubMed)

Other Identifiers

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B2011:051

Identifier Type: -

Identifier Source: org_study_id

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