protocolSection identificationModule nctId: NCT06292195, orgStudyIdInfo id: VitDTracking, briefTitle: Effects of Vitamin D on Health Promotion During Pregnancy and Its Impact on Prematurity-Related Outcome, acronym: VitDTracking, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-03, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Évora, class: OTHER, collaborators name: Comprehensive Health Research Centre, collaborators name: Unidade Local De Saúde Do Norte Alentejano, collaborators name: Unidade local de Saúde do Baixo Alentejano, collaborators name: Unidade Local de Saúde do Alentejo Central, collaborators name: Universidade Nova de Lisboa, collaborators name: Instituto de Engenharia de Sistemas e Computadores - Inovação e Desenvolvimento de Lisboa (INESC-ID), descriptionModule briefSummary: The VitDTracking study focuses on the relevance of maternal vitamin D levels and their association with prematurity, aiming to improve maternal and child health outcomes, particularly by reducing avoidable preterm births. In Portugal, vitamin D levels during pregnancy have never been studied. Epidemiological data from other countries reveal a high prevalence of vitamin D deficiency/insufficiency, especially in pregnant women.The hypovitaminoses prevalence remains high even with a supplementation dosage of 400 to 600 IU/day during pregnancy (dosage used in Portugal), which is considered as a suboptimal dose. This phenomenon is associated with adverse maternal and child outcomes, such as intrauterine growth restriction, preeclampsia, cholestasis, hypertension, and gestational diabetes as major causes of prematurity.Additionally, the Portuguese population has a higher prevalence of genome alterations that confer a lower capacity to produce vitamin D from sunlight exposure. These genetic characteristics are present in about 19% of the population, representing a prevalence four times higher than the European average (19% versus 4.75%), leading to a higher predisposition to vitamin D deficiency., conditionsModule conditions: Vitamin D Deficiency, conditions: Pregnancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Exposure, outcomesModule primaryOutcomes measure: Differences in the rate of Prematurity with different maternal Vitamin D levels, primaryOutcomes measure: Differences in Birth Weight with different maternal Vitamin D levels, primaryOutcomes measure: Differences in Apgar Scores with different maternal Vitamin D levels, primaryOutcomes measure: Differences in the number of admissions to the Neonatal Intensive Care Unit with different maternal Vitamin D levels, primaryOutcomes measure: Differences in the Neonatal Morbidity rate with different maternal Vitamin D levels, primaryOutcomes measure: Differences in the Neonatal Mortality rate with different maternal Vitamin D levels, primaryOutcomes measure: Differences in the number of Neonatal Infections with different maternal Vitamin D levels, primaryOutcomes measure: Differences in the Number of Congenital Malformation diagnoses with different maternal vitamin D levels, primaryOutcomes measure: Differences in the presence of vitamin D-related polymorphisms with different maternal levels of vitamin D, secondaryOutcomes measure: Differences in maternal vitamin D levels between the three groups/cohorts related to prematurity, secondaryOutcomes measure: Differences in maternal vitamin D levels between the three groups/cohorts related to birth weight, secondaryOutcomes measure: Differences in maternal vitamin D levels between the three groups/cohorts related to Apgar scores, secondaryOutcomes measure: Differences in maternal vitamin D levels between the three groups/cohorts related to admission to the Neonatal Intensive Care Unit, secondaryOutcomes measure: Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal morbidity, secondaryOutcomes measure: Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal mortality, secondaryOutcomes measure: Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal infections., secondaryOutcomes measure: Differences in maternal vitamin D levels between the three groups/cohorts related to the diagnosis of congenital malformations, secondaryOutcomes measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with prematurity, secondaryOutcomes measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with birth weight, secondaryOutcomes measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with Apgar scores, secondaryOutcomes measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with admission to the Neonatal Intensive Care Unit., secondaryOutcomes measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal morbidity, secondaryOutcomes measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal mortality, secondaryOutcomes measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal infections, secondaryOutcomes measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with the diagnosis of congenital malformations, eligibilityModule sex: FEMALE, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unidade Local de Saúde do Baixo Alentejo, status: RECRUITING, city: Beja, zip: 7801-849, country: Portugal, contacts name: Inês Gornilho, MD, role: CONTACT, email: ines.gornilho@ulsba.min-saude.pt, geoPoint lat: 38.01506, lon: -7.86323, locations facility: Unidade Local de Saúde do Norte Alentejano, status: RECRUITING, city: Portalegre, zip: 7301-853, country: Portugal, contacts name: Vera Escoto, MD, role: CONTACT, email: veraescoto.ca@ulsaale.min-saude.pt, geoPoint lat: 39.29379, lon: -7.43122, locations facility: Unidade Local de Saúde do Alentejo Central - Hospital Espirito Santo de Évora, status: RECRUITING, city: Évora, zip: 7000-811, country: Portugal, contacts name: Maria OP Barbosa, MSc; PhD Student, role: CONTACT, phone: 00351966056178, email: mobarbosa@hevora.min-saude.pt, contacts name: Fernando Fernandes, MD, role: CONTACT, phone: 00351965753123, email: ffernandes@hevora.min-saude.pt, geoPoint lat: 38.56667, lon: -7.9, hasResults: False