Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-07 @ 6:48 PM
Study NCT ID:
NCT03197233
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2017-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin A and D Intake in Pregnancy, Infant Supplementation and Asthma Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61676}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-23', 'studyFirstSubmitDate': '2017-06-19', 'studyFirstSubmitQcDate': '2017-06-22', 'lastUpdatePostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child asthma based on dispensed asthma medications', 'timeFrame': 'A minimum of two dispensations around age 7 years', 'description': 'Dispensations of antiasthmatics (Anatomical Therapeutic Chemical Classification/ATC codes R03AC, R03BA, R03AK, and R03DC) registered in the Norwegian Prescription Database'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma in Children']}, 'referencesModule': {'references': [{'pmid': '27063603', 'type': 'BACKGROUND', 'citation': 'Magnus P, Birke C, Vejrup K, Haugan A, Alsaker E, Daltveit AK, Handal M, Haugen M, Hoiseth G, Knudsen GP, Paltiel L, Schreuder P, Tambs K, Vold L, Stoltenberg C. Cohort Profile Update: The Norwegian Mother and Child Cohort Study (MoBa). Int J Epidemiol. 2016 Apr;45(2):382-8. doi: 10.1093/ije/dyw029. Epub 2016 Apr 10.'}, {'pmid': '17031521', 'type': 'BACKGROUND', 'citation': 'Ronningen KS, Paltiel L, Meltzer HM, Nordhagen R, Lie KK, Hovengen R, Haugen M, Nystad W, Magnus P, Hoppin JA. The biobank of the Norwegian Mother and Child Cohort Study: a resource for the next 100 years. Eur J Epidemiol. 2006;21(8):619-25. doi: 10.1007/s10654-006-9041-x. Epub 2006 Sep 20.'}, {'pmid': '29722838', 'type': 'DERIVED', 'citation': 'Parr CL, Magnus MC, Karlstad O, Holvik K, Lund-Blix NA, Haugen M, Page CM, Nafstad P, Ueland PM, London SJ, Haberg SE, Nystad W. Vitamin A and D intake in pregnancy, infant supplementation, and asthma development: the Norwegian Mother and Child Cohort. Am J Clin Nutr. 2018 May 1;107(5):789-798. doi: 10.1093/ajcn/nqy016.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate if maternal intake of vitamins A and D from food and dietary supplements during pregnancy, and infant supplementation with these vitamins, are associated with development of asthma in the offspring.', 'detailedDescription': 'This study was conducted as part of the research project "Causal pathways for asthma" funded by the Norwegian Research Council (2013-2017). The overall objective was to study if different pregnancy and early life exposures affect the risk of asthma and allergic diseases in children, and if these exposures exert their effects through epigenetic mechanisms, more specifically DNA methylation.\n\nFor this project, including the current study, existing data from the Norwegian Mother and Child Study (MoBa file version 9, 115 398 children and 95 248 mothers) were linked with the Medical Birth Registry of Norway and the Norwegian Prescription Database. The MoBa study recruited pregnant women between 1999 and 2008, at approximately 18 weeks of gestation. Beginning 2002, women completed a food frequency questionnaire about dietary intake (food and supplements) in pregnancy. A panel of maternal plasma biomarkers, including plasma retinol and 25-hydroxyvitamin D2 and D3, was available for a random sample of around 3,000 women who gave birth in 2002 and 2003.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The Norwegian Mother and Child Study is a population-based pregnancy cohort (births 1999-2009). Women were recruited nationwide (41% participation) around 18 weeks gestation. The current study included 61,676 eligible chidren born 2002-2007.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAvailable maternal dietary intake data from pregnancy. Child turned 7 years by July 1st 2014.\n\nExclusion Criteria:\n\nNo maternal baseline questionnaire. Maternal energy intake \\<4,500 or \\> 20,000 kJ. No dietary supplement data. No linkage to national birth registry, or non-live births, or multiple births. Child death, or emigration, or unknown vital status.'}, 'identificationModule': {'nctId': 'NCT03197233', 'briefTitle': 'Vitamin A and D Intake in Pregnancy, Infant Supplementation and Asthma Development', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Norwegian Institute of Public Health'}, 'officialTitle': 'Norwegian Mother and Child Study - Causal Pathways for Asthma (CASPAR)', 'orgStudyIdInfo': {'id': 'PDB532_journal 08/2602-29'}, 'secondaryIdInfos': [{'id': '221097', 'type': 'OTHER_GRANT', 'domain': 'Norwegian Research Council/BIOBANK program'}, {'id': 'ZO1ES49019', 'type': 'OTHER_GRANT', 'domain': 'National Institute of Environmental Health Sciences'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Maternal vitamin A and D intake during pregnancy', 'type': 'OTHER', 'otherNames': ['Total vitamin A and D intake from food and supplements'], 'description': 'Dietary exposures during pregnancy and infant supplement use were assessed from maternal questionnaire report'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Wenche Nystad, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Non-Communicable Diseases, Norwegian Institute of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data have been shared with collaborators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian Institute of Public Health', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}