Effects of Vitamin D on Health Promotion During Pregnancy and Its Impact on Prematurity-Related Outcome
NCT ID: NCT06292195
Last Updated: 2024-03-05
Study Results
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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RECRUITING
1000 participants
OBSERVATIONAL
2023-11-03
2025-12-31
Brief Summary
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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.
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Detailed Description
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The study will measure vitamin D levels during pregnancy and their impact on outcome indicators related to prematurity. The aim is to assess the impact of the prevalence of vitamin D deficiency on prematurity outcomes. This involves monitoring vitamin D levels in prenatal and postnatal surveillance, adding this biomarker to routine blood collections. Biometric and biochemical data collection will occur at two distinct time points. The first collection will take place during the first prenatal surveillance appointment, preferably in the first trimester. The second collection will occur postpartum, during the hospitalization period.
The study will also assess maternal vitamin D deficiency and associated factors in the Alentejo region. It aims to identify the existence of genetic polymorphisms related to vitamin D and assess associations with adverse clinical outcomes related to prematurity. This involves requesting genetic analysis by the local medical collaborator and collecting saliva from the pregnant woman (non-invasive method) for the study of polymorphisms in seven genes, integrating the analysis of 18 genetic variants that play a role in the metabolism, transport, degradation and downstream pathways of vitamin D. Saliva samples from pregnant women will be collected during hospitalization before or after birth.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort VitDTracking: Group 1- Pregnant women with vitamin D Sufficiency (≥30 ng/mL)
Exposure
Maternal vitamin D levels during pregnancy (serum 25-hydroxyvitamin D levels)
Cohort VitDTracking: Group 2 - Pregnant women with vitamin D Insufficiency (20-29 ng/mL)
Exposure
Maternal vitamin D levels during pregnancy (serum 25-hydroxyvitamin D levels)
Cohort VitDTracking: Group 3 - Pregnant women with vitamin D Deficiency (<20 ng/mL)
Exposure
Maternal vitamin D levels during pregnancy (serum 25-hydroxyvitamin D levels)
Interventions
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Exposure
Maternal vitamin D levels during pregnancy (serum 25-hydroxyvitamin D levels)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
FEMALE
Yes
Sponsors
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Comprehensive Health Research Center
OTHER
Unidade Local De Saúde Do Norte Alentejano
OTHER
Unidade local de Saúde do Baixo Alentejano
UNKNOWN
Unidade Local de Saúde do Alentejo Central
UNKNOWN
Universidade Nova de Lisboa
OTHER
Instituto de Engenharia de Sistemas e Computadores - Inovação e Desenvolvimento de Lisboa (INESC-ID)
UNKNOWN
University of Évora
OTHER
Responsible Party
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Maria Olívia Pereira Barbosa
Principal Investigator; MSc; PhD student
Principal Investigators
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Maria OP Barbosa, MSc; PhD student
Role: PRINCIPAL_INVESTIGATOR
University of Évora
Dulce Cruz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Évora
André Rosário, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade Nova de Lisboa
Marta Silvestre, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade Nova de Lisboa
Ana T Freitas, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Engenharia de Sistemas e Computadores - Inovação e Desenvolvimento de Lisboa (INESC-ID)
Locations
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Unidade Local de Saúde do Baixo Alentejo
Beja, , Portugal
Unidade Local de Saúde do Alentejo Central - Hospital Espirito Santo de Évora
Evora, , Portugal
Unidade Local de Saúde do Norte Alentejano
Portalegre, , Portugal
Countries
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Central Contacts
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Facility Contacts
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References
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Barbosa O, Freitas AT, Silvestre MP, Moreira-Rosario A, Aguiar P, Regua AI, Madaleno T, Almeida M, Cruz D. Effects of Maternal Vitamin D Levels on Prematurity: Feasibility Study in a Multicenter Observational Pilot. Nutrients. 2025 Mar 27;17(7):1160. doi: 10.3390/nu17071160.
Other Identifiers
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VitDTracking
Identifier Type: -
Identifier Source: org_study_id
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