Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 10:56 PM
Study NCT ID:
NCT01942434
Status:
COMPLETED
Last Update Posted:
2020-12-16
First Post:
2013-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fatty Acid Levels and Memory in Breastfed Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'saliva, blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2013-09-06', 'studyFirstSubmitQcDate': '2013-09-10', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relation between recognition memory and maternal FADS genotype', 'timeFrame': '6 months', 'description': 'At 6 months of age, during the second session (Phase 2)'}], 'secondaryOutcomes': [{'measure': 'Nutrient content of breastmilk as it relates to FADS genotype', 'timeFrame': '3 to 4 months', 'description': 'Sample provided in session 1 when the infant was 3-4 months old (Phase 1)'}, {'measure': 'Nutrient content of breastmilk as it relates to recognition memory', 'timeFrame': '6 months', 'description': 'At 6 months of age, during the second session (Phase 2)'}, {'measure': 'Relation between declarative memory and breastmilk nutrients', 'timeFrame': '26 or 38 months', 'description': 'At session 3, when the child was either 26 or 38 months of age (Phase 3)'}, {'measure': 'Relation between declarative memory and concurrent nutrients', 'timeFrame': '26 or 38 months', 'description': 'At session 3, when the child was either 26 or 38 months of age (Phase 3)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fatty acids', 'Breast milk nutrients', 'Cognitive development', 'Electrophysiology', 'Long-term assessment'], 'conditions': ['Cognitive Development']}, 'descriptionModule': {'briefSummary': 'Purpose: To explore the relation between breastmilk nutrients and the cognitive abilities of breastfed infants.\n\nPhase 1: Near 3 months of age child and mother saliva samples for DNA obtained with breast milk sample.\n\nPhase 2: At 6 months of age child participates in electrophysiology session to test recognition memory.\n\nPhase 3: At 26 or 38 months of age, children will complete behavioral, dietary, and physical assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'minimumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breastfeeding infants and their mothers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* typically-developing\n* exclusively breastfed\n* unremarkable delivery\n\nExclusion Criteria:\n\n* non-English speaking\n* history of seizure activity'}, 'identificationModule': {'nctId': 'NCT01942434', 'briefTitle': 'Fatty Acid Levels and Memory in Breastfed Children', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'The Influence of FADS2 rs 174575 on Breastmilk Fatty Acid Levels and the Recognition Memory Abilities of 6-month Old Breastfed Infants and Follow-up', 'orgStudyIdInfo': {'id': '09-1869'}}, 'contactsLocationsModule': {'locations': [{'zip': '28081', 'city': 'Kannapolis', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Nutrition Research Institute', 'geoPoint': {'lat': 35.48736, 'lon': -80.62173}}], 'overallOfficials': [{'name': 'Carol L Cheatham, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC at Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychology', 'investigatorFullName': 'Carol Cheatham, PhD', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}