The Reus-Tarragona Birth Cohort Study of Early Development and Ageing.

NCT ID: NCT01778205

Last Updated: 2021-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

831 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2020-09-14

Brief Summary

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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.

Detailed Description

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Conditions

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Intrauterine Development

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women

Pregnant women with confirmed viable fetus at first prenatal check-up at \<12 gestational weeks

Observational

Intervention Type OTHER

Interventions

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Observational

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \<12 weeks pregnant at first prenatal check up

Exclusion Criteria

* Illnesses / interventions affecting nutritional status, major recent surgery in the previous 6 months, multiple pregnancies
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Italfarmaco

INDUSTRY

Sponsor Role collaborator

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

State Research Agency, Spain

OTHER_GOV

Sponsor Role collaborator

JPI ERA-HDHL

UNKNOWN

Sponsor Role collaborator

University Rovira i Virgili

OTHER

Sponsor Role collaborator

European Regional Development Fund

OTHER

Sponsor Role collaborator

Institut Investigacio Sanitaria Pere Virgili

OTHER

Sponsor Role lead

Responsible Party

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Dr. Michelle Murphy

Profesora agregat

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle M Murphy, PhD

Role: PRINCIPAL_INVESTIGATOR

University Rovira i Virgili

Pere Cavallé-Busquets, MD, PHD

Role: STUDY_DIRECTOR

Hospital Universitari Sant Joan de Reus

Joan D Fernandez-Ballart, PhD

Role: STUDY_CHAIR

University Rovira i Virgili

Mónica Ballesteros, MD, PHD

Role: STUDY_DIRECTOR

Hospital de Tarragona Joan XXIII

Locations

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Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain

Site Status

Hospital de Tarragona Joan XXIII

Tarragona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 27735840 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29529156 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30777448 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31962182 (View on PubMed)

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.

Reference Type RESULT
PMID: 23595875 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39326699 (View on PubMed)

Other Identifiers

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SPAIN MICINN

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SPAIN ISCIII

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SPAIN URV

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SPAIN ISCIII

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SPAIN ISCIII

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SPAIN AEI

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Horizon 2020

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IISPV_Murphy1

Identifier Type: -

Identifier Source: org_study_id

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