Effects of Vitamin D on Health Promotion During Pregnancy and Its Impact on Prematurity-Related Outcome Indicators in the Alentejo Region

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Healthy Volunteers: t
View:

• Pregnant women's living in the Alentejo region aged 16 years or older, who after disclosure and clarification of doubts, agree to participate in the study with signed informed consent.

Locations
Other Locations
Portugal
Unidade Local de Saúde do Baixo Alentejo
RECRUITING
Beja
Unidade Local de Saúde do Alentejo Central - Hospital Espirito Santo de Évora
RECRUITING
Evora
Unidade Local de Saúde do Norte Alentejano
RECRUITING
Portalegre
Contact Information
Primary
Maria OP Barbosa, MSc; PhD student
d52901@alunos.uevora.pt
00351966056178
Backup
Dulce Cruz, PhD
dcruz@uevora.pt
00351969106244
Time Frame
Start Date: 2023-11-03
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1000
Treatments
Cohort VitDTracking: Group 1- Pregnant women with vitamin D Sufficiency (≥30 ng/mL)
Cohort VitDTracking: Group 2 - Pregnant women with vitamin D Insufficiency (20-29 ng/mL)
Cohort VitDTracking: Group 3 - Pregnant women with vitamin D Deficiency (<20 ng/mL)
Sponsors
Collaborators: Instituto de Engenharia de Sistemas e Computadores - Inovação e Desenvolvimento de Lisboa (INESC-ID), Unidade local de Saúde do Baixo Alentejano, Unidade Local de Saúde do Alentejo Central, Universidade Nova de Lisboa, Comprehensive Health Research Center, Unidade Local De Saúde Do Norte Alentejano
Leads: University of Évora

This content was sourced from clinicaltrials.gov