Effects of Vitamin D on Health Promotion During Pregnancy and Its Impact on Prematurity-Related Outcome

NCT06292195 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-03-05

No results posted yet for this study

Summary

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.

Conditions

  • Vitamin D Deficiency
  • Pregnancy

Interventions

OTHER

Exposure

Maternal vitamin D levels during pregnancy (serum 25-hydroxyvitamin D levels)

Sponsors & Collaborators

  • Comprehensive Health Research Center

    collaborator OTHER
  • Unidade Local De Saúde Do Norte Alentejano

    collaborator OTHER
  • Unidade local de Saúde do Baixo Alentejano

    collaborator UNKNOWN
  • Unidade Local de Saúde do Alentejo Central

    collaborator UNKNOWN
  • Universidade Nova de Lisboa

    collaborator OTHER
  • Instituto de Engenharia de Sistemas e Computadores - Inovação e Desenvolvimento de Lisboa (INESC-ID)

    collaborator UNKNOWN
  • University of Évora

    lead OTHER

Principal Investigators

  • Maria OP Barbosa, MSc; PhD student · University of Évora

  • Dulce Cruz, PhD · University of Évora

  • André Rosário, PhD · Universidade Nova de Lisboa

  • Marta Silvestre, PhD · Universidade Nova de Lisboa

  • Ana T Freitas, PhD · Instituto de Engenharia de Sistemas e Computadores - Inovação e Desenvolvimento de Lisboa (INESC-ID)

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-03
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06292195 on ClinicalTrials.gov