Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-01-14 @ 1:19 AM
Study NCT ID:
NCT03305900
Status:
COMPLETED
Last Update Posted:
2017-10-10
First Post:
2017-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determinants of Formate Concentrations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1701}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2013-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-04', 'studyFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2017-10-04', 'lastUpdatePostDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Formate concentrations', 'timeFrame': 'Single baseline measurement; cross sectional, observational study', 'description': 'Formate concentrations in study population'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['formate', 'one-carbon metabolism'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '29566195', 'type': 'DERIVED', 'citation': 'Brosnan JT, Mills JL, Ueland PM, Shane B, Fan R, Chiu CY, Pangilinan F, Brody LC, Brosnan ME, Pongnopparat T, Molloy AM. Lifestyle, metabolite, and genetic determinants of formate concentrations in a cross-sectional study in young, healthy adults. Am J Clin Nutr. 2018 Mar 1;107(3):345-354. doi: 10.1093/ajcn/nqx065.'}]}, 'descriptionModule': {'briefSummary': 'Formate is an important metabolite, serving as a donor of one-carbon groups to the intracellular tetrahydrofolate pool. However, little is known of its circulating concentrations or of their determinants. This study seeks to define formate levels and their determinants in a young, healthy population.\n\nSerum formate will be measured in 1701 subjects from the Trinity Student Study. The subjects, males and females, aged 18 to 28 years, were enrolled at Trinity College, Dublin. Formate levels will be compared with other one-carbon metabolites, vitamin status, potential formate precursors, genetic polymorphisms, and lifestyle factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Serum formate was measured in 1701 subjects from the Trinity Student Study. The subjects, males and females, aged 18 to 28 years, were enrolled at Trinity College, Dublin', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trinity College Dublin students with Irish grandparents\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03305900', 'briefTitle': 'Determinants of Formate Concentrations', 'organization': {'class': 'OTHER', 'fullName': 'Memorial University of Newfoundland'}, 'officialTitle': 'Lifestyle, Metabolite and Genetic Determinants of Formate Concentrations in a Cross-sectional Study of Young, Healthy Adults', 'orgStudyIdInfo': {'id': '12.190 HREA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'Cross-sectional study requiring a single serum sample'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anne Molloy, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Dublin, Trinity College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial University of Newfoundland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Dublin, Trinity College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Biochemistry', 'investigatorFullName': 'John (Sean) Brosnan', 'investigatorAffiliation': 'Memorial University of Newfoundland'}}}}