Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-01 @ 6:15 AM
Study NCT ID:
NCT01778205
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2013-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Reus-Tarragona Birth Cohort Study of Early Development and Ageing.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma Serum Leukocytes Placenta'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 831}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-16', 'studyFirstSubmitDate': '2013-01-25', 'studyFirstSubmitQcDate': '2013-01-25', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '1-C metabolites', 'timeFrame': '<12, 15, 24-27, 34 gestational weeks, at labor, in the cord'}, {'measure': 'Intrauterine growth retardation', 'timeFrame': 'At birth'}], 'primaryOutcomes': [{'measure': 'Birth weight', 'timeFrame': 'At birth'}, {'measure': 'Doppler waveforms of uterine arteries', 'timeFrame': '20 gestational weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intrauterine Development']}, 'referencesModule': {'references': [{'pmid': '27735840', 'type': 'BACKGROUND', 'citation': 'Colomina JM, Cavalle-Busquets P, Fernandez-Roig S, Sole-Navais P, Fernandez-Ballart JD, Ballesteros M, Ueland PM, Meyer K, Murphy MM. Maternal Folate Status and the BHMT c.716G>A Polymorphism Affect the Betaine Dimethylglycine Pathway during Pregnancy. Nutrients. 2016 Oct 9;8(10):621. doi: 10.3390/nu8100621.'}, {'pmid': '29529156', 'type': 'BACKGROUND', 'citation': 'Sole-Navais P, Salat-Batlle J, Cavalle-Busquets P, Fernandez-Ballart J, Ueland PM, Ballesteros M, Ornosa-Martin G, Ingles-Puig M, Colomina JM, Murphy MM. Early pregnancy folate-cobalamin interactions and their effects on cobalamin status and hematologic variables throughout pregnancy. Am J Clin Nutr. 2018 Feb 1;107(2):173-182. doi: 10.1093/ajcn/nqx041.'}, {'pmid': '30777448', 'type': 'BACKGROUND', 'citation': 'Roige-Castellvi J, Murphy M, Hernandez-Martinez C, Sole-Navais P, Cavalle-Busquets P, Fernandez-Ballart J, Ballesteros M, Canals J. The effect of prenatal smoke exposure on child neuropsychological function: a prospective mother-child cohort study. J Reprod Infant Psychol. 2020 Feb;38(1):25-37. doi: 10.1080/02646838.2019.1580350. Epub 2019 Feb 19.'}, {'pmid': '31962182', 'type': 'BACKGROUND', 'citation': 'Cavalle-Busquets P, Ingles-Puig M, Fernandez-Ballart JD, Haro-Barcelo J, Rojas-Gomez A, Ramos-Rodriguez C, Ballesteros M, Meyer K, Ueland PM, Murphy MM. Moderately elevated first trimester fasting plasma total homocysteine is associated with increased probability of miscarriage. The Reus-Tarragona Birth Cohort Study. Biochimie. 2020 Jun;173:62-67. doi: 10.1016/j.biochi.2020.01.008. Epub 2020 Jan 18.'}, {'pmid': '23595875', 'type': 'RESULT', 'citation': 'Fernandez-Roig S, Cavalle-Busquets P, Fernandez-Ballart JD, Ballesteros M, Berrocal-Zaragoza MI, Salat-Batlle J, Ueland PM, Murphy MM. Low folate status enhances pregnancy changes in plasma betaine and dimethylglycine concentrations and the association between betaine and homocysteine. Am J Clin Nutr. 2013 Jun;97(6):1252-9. doi: 10.3945/ajcn.112.054189. Epub 2013 Apr 17.'}, {'pmid': '39326699', 'type': 'DERIVED', 'citation': 'Santos-Calderon LA, Cavalle-Busquets P, Ramos-Rodriguez C, Grifoll C, Rojas-Gomez A, Ballesteros M, Ueland PM, Murphy MM. Folate and cobalamin status, indicators, modulators, interactions, and reference ranges from early pregnancy until birth: the Reus-Tarragona birth cohort study. Am J Clin Nutr. 2024 Nov;120(5):1269-1283. doi: 10.1016/j.ajcnut.2024.09.015. Epub 2024 Sep 24.'}]}, 'descriptionModule': {'briefSummary': "The recent fall in birth and death rates has led to demographic changes such as low fertility and high life expectancy . The WHO reports the median age of the European population to be the highest in the world and predicts that the proportion of over-60s in will increase from 14% in 2010 to 25% in 2050. There is wide variability in the quality of health and well-being in the ageing population. Longevity with a good quality of life is a consequence of the combination of an individual's genes, nutrition, environment, lifestyle and medical interventions. There is increasing evidence that research into healthy ageing needs to start with early life data to capture all traits and exposures experienced by an individual throughout life. Epigenetic imprinting occurs both in utero and during early postnatal development. Maternal environmental exposures, including nutritional status, may have a permanent effect on the developing foetus by influencing epigenetic profiles and leading to life-long genome adaptation. Numerous reports show that restricted intra-uterine growth due to poor maternal nutrition during pregnancy increases risk in the offspring of developing mental disorders, metabolic syndrome, cardiovascular disease or stroke in later life. To understand the basic mechanisms and interactions through which the ageing phenotype develops, systems involved in key processes of early development must be considered as well as those crucial to health in older persons. The Reus and Tarragona Birth Cohort is a longitudinal study. In the first phase, blood is collected from pregnant women at \\<12, 15, 24-27 and 34 gestational weeks (GW) and at labor and from the cord. Detailed lifestyle, habits and supplement use data are collected at 20 and 32 gestational weeks and on nutritional habits at \\<12GW and at birth. Placental vascular function is assessed at 20 and 32 GW by analysis of Doppler waveforms of the uterine arteries. Data on pregnancy evolution and outcome are also recorded. The first phase investigates the association between gene-environment (nutrient and lifestyle habits) interactions and fetal growth and pregnancy outcome. The second phase of the study follows up the children at 7.5 years of age. Growth, exercise and nutritional habits as well as environment and cognitive development are assessed. The aims are to investigate the association between gene-environment interactions associated with healthy development from early pregnancy until 7.5 years of age."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women less than 12 weeks pregnant at their first pre-natal check up are recruited from the URV University Hospitals: Sant Joan (Reus) and Joan XXIII (Tarragona)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<12 weeks pregnant at first prenatal check up\n\nExclusion Criteria:\n\n* Illnesses / interventions affecting nutritional status, major recent surgery in the previous 6 months, multiple pregnancies'}, 'identificationModule': {'nctId': 'NCT01778205', 'briefTitle': 'The Reus-Tarragona Birth Cohort Study of Early Development and Ageing.', 'organization': {'class': 'OTHER', 'fullName': 'Institut Investigacio Sanitaria Pere Virgili'}, 'officialTitle': 'Phase 1 Study of the Effect of Maternal Nutritional Status on Placental Vascular Function, Fetal Growth and Intrauterine Growth Retardation.', 'orgStudyIdInfo': {'id': 'IISPV_Murphy1'}, 'secondaryIdInfos': [{'id': 'SPAIN MICINN', 'type': 'OTHER_GRANT', 'domain': 'Ministerio de Ciéncia y Innovación SAF2005/05096'}, {'id': 'SPAIN ISCIII', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III PI10/00335'}, {'id': 'SPAIN URV', 'type': 'OTHER_GRANT', 'domain': 'Universitat Rovira i Virgili'}, {'id': 'SPAIN ISCIII', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III PI13/02500'}, {'id': 'SPAIN ISCIII', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III PI19/00844'}, {'id': 'SPAIN AEI', 'type': 'OTHER_GRANT', 'domain': 'Agencia Estatal Investigacion PCI2018-093098'}, {'id': 'Horizon 2020', 'type': 'OTHER_GRANT', 'domain': 'JPI ERA-HDHL Nutrition & The Epigenome'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women', 'description': 'Pregnant women with confirmed viable fetus at first prenatal check-up at \\<12 gestational weeks', 'interventionNames': ['Other: Observational']}], 'interventions': [{'name': 'Observational', 'type': 'OTHER', 'armGroupLabels': ['Pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43201', 'city': 'Reus', 'state': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Universitari Sant Joan de Reus', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}, {'zip': '43005', 'city': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital de Tarragona Joan XXIII', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}], 'overallOfficials': [{'name': 'Michelle M Murphy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Rovira i Virgili'}, {'name': 'Pere Cavallé-Busquets, MD, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitari Sant Joan de Reus'}, {'name': 'Joan D Fernandez-Ballart, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Rovira i Virgili'}, {'name': 'Mónica Ballesteros, MD, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital de Tarragona Joan XXIII'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Investigacio Sanitaria Pere Virgili', 'class': 'OTHER'}, 'collaborators': [{'name': 'Italfarmaco', 'class': 'INDUSTRY'}, {'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}, {'name': 'State Research Agency, Spain', 'class': 'OTHER_GOV'}, {'name': 'JPI ERA-HDHL', 'class': 'UNKNOWN'}, {'name': 'University Rovira i Virgili', 'class': 'OTHER'}, {'name': 'European Regional Development Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Profesora agregat', 'investigatorFullName': 'Dr. Michelle Murphy', 'investigatorAffiliation': 'Institut Investigacio Sanitaria Pere Virgili'}}}}