Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2026-02-23 @ 7:12 PM
Study NCT ID:
NCT01584206
Status:
COMPLETED
Last Update Posted:
2020-01-30
First Post:
2012-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sitosterolemia Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537345', 'term': 'Sitosterolemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069438', 'term': 'Ezetimibe'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-29', 'studyFirstSubmitDate': '2012-04-16', 'studyFirstSubmitQcDate': '2012-04-23', 'lastUpdatePostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma cholesterol level', 'timeFrame': '8 months', 'description': 'Plasma cholesterol level will be assessed by GC'}, {'measure': 'Plasma sitosterol level', 'timeFrame': '8 months', 'description': 'Plasma plant sterol assessment using GC'}], 'secondaryOutcomes': [{'measure': 'Cholesterol absorption', 'timeFrame': '4 month', 'description': 'Use stable isotope technique to assess cholesterol absorption'}, {'measure': 'Cholesterol synthesis', 'timeFrame': '4 months', 'description': 'Use of stable isotope to assess cholesterol synthesis.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sitosterolemia', 'Ezetimibe', 'Plant sterol', 'Cholesterol'], 'conditions': ['Sitosterolemia']}, 'referencesModule': {'references': [{'pmid': '28625503', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '25444527', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed diagnosis of homozygous sitosterolemia as established by genotyping and clinical parameters\n\nExclusion Criteria:\n\n* pregnant\n* intellectual disability\n* major infectious diseases\n* immunodeficiency\n* cancer\n* renal failure\n* diabetes'}, 'identificationModule': {'nctId': 'NCT01584206', 'acronym': 'STAIR7002', 'briefTitle': 'Sitosterolemia Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Assessment of Sterol Metabolism in Sitosterolemia: A Pilot Study of Patients Treated With Ezetimibe', 'orgStudyIdInfo': {'id': 'B2011:051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ezetimibe', 'description': 'Compare on and off ezetimibe', 'interventionNames': ['Drug: Ezetimibe']}], 'interventions': [{'name': 'Ezetimibe', 'type': 'DRUG', 'description': '10mg ezetimibe/day, at least 4 months', 'armGroupLabels': ['Ezetimibe']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3T 2N2', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Richardson Centre for Functional Foods and Nutraceuticals', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Semone B Myrie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}, {'name': 'Peter J Jones, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Manitoba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}