Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-02 @ 12:36 AM
Study NCT ID:
NCT03468959
Status:
COMPLETED
Last Update Posted:
2023-12-29
First Post:
2018-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Polyunsaturated Fatty Acids in Association With Child Autism Spectrum Disorder in the MARBLES Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-28', 'studyFirstSubmitDate': '2018-02-09', 'studyFirstSubmitQcDate': '2018-03-12', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'A group of non-typical development (Non-TD) people', 'timeFrame': '36 months', 'description': 'number of people with non-typical development'}], 'primaryOutcomes': [{'measure': 'autism spectrum disorder group (ASD)', 'timeFrame': '36 months', 'description': 'number of people with ASD'}], 'secondaryOutcomes': [{'measure': 'A group of typically development (TD) people', 'timeFrame': '36 months', 'description': 'number of typically developed people'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'This study is to examine the association between maternal omega3 and other polyunsaturated fatty acids (PUFAs) during pregnancy and autism spectrum disorder (ASD) as well as other non-typical development (Non-TD) in the prospective Markers of Autism Risk in Babies-Learning Early Signs (MARBLES) cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Families were recruited from lists of children receiving autism services obtained via the California Department of Developmental Services (DDS), from other studies at the Medical Investigation of Neurodevelopmental Disorders (MIND) Institute, or by self-referrals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mother or father had a biological child with ASD\n* Mother is at least 18 years old\n* Mother is pregnant or planning a pregnancy, and biologically able to become pregnant\n* Mother is living within 2 hours of the MIND Institute\n* Mother is sufficiently fluent in English\n\nExclusion Criteria:\n\n* Mothers with diseases which will influence on their study participation'}, 'identificationModule': {'nctId': 'NCT03468959', 'briefTitle': 'Maternal Polyunsaturated Fatty Acids in Association With Child Autism Spectrum Disorder in the MARBLES Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Maternal Polyunsaturated Fatty Acids in Association With Child Autism Spectrum Disorder in the MARBLES Study', 'orgStudyIdInfo': {'id': '225645'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mother-child pairs', 'description': 'Families were recruited from lists of children receiving autism services obtained via the California Department of Developmental Services (DDS), from other studies at the Medical Investigation of Neurodevelopmental Disorders (MIND) Institute, or by self-referrals. The inclusion criteria were: a) mother or father had a biological child with ASD, and the mother was b) at least 18 years old; c) pregnant or planning a pregnancy, and biologically able to become pregnant; d) living within 2 hours of the MIND Institute; e) sufficiently fluent in English.', 'interventionNames': ['Behavioral: Maternal Supplemental PUFA Intake']}], 'interventions': [{'name': 'Maternal Supplemental PUFA Intake', 'type': 'BEHAVIORAL', 'description': 'Maternal Supplemental PUFA Intake included sources from the questionnaires and plasma', 'armGroupLabels': ['Mother-child pairs']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}