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

Pregnancy Clinical Trial

— VitDTracking  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06292195
• Other study ID #: VitDTracking
• Status: Recruiting
• Start date: November 3, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: University of Évora
• Contact: Maria OP Barbosa, MSc; PhD student
• Phone: 00351966056178
• Email: d52901[@]alunos.uevora.pt
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

This observational study involves the implementation of multicenter recruitment centers. Data collection will take place in healthcare organizations in the Alentejo region (Évora, Beja, Portalegre, and Elvas) with a minimum total sample of 1000 pregnant women, integrating both primary and specialized healthcare, with local healthcare professionals, doctors, and nurses as collaborators.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Language barrier (lack of basic understanding of Portuguese).

Related Conditions & MeSH terms

• Pregnancy
• Premature Birth
• Vitamin D Deficiency

Intervention

Other:
• Exposure
Maternal vitamin D levels during pregnancy (serum 25-hydroxyvitamin D levels)

Locations

Country	Name	City	State
Portugal	Unidade Local de Saúde do Baixo Alentejo	Beja
Portugal	Unidade Local de Saúde do Alentejo Central - Hospital Espirito Santo de Évora	Évora
Portugal	Unidade Local de Saúde do Norte Alentejano	Portalegre

Sponsors (7)

Lead Sponsor	Collaborator
University of Évora	Comprehensive Health Research Centre, Instituto de Engenharia de Sistemas e Computadores - Inovação e Desenvolvimento de Lisboa (INESC-ID), Unidade Local de Saúde do Alentejo Central, Unidade local de Saúde do Baixo Alentejano, Unidade Local De Saúde Do Norte Alentejano, Universidade Nova de Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in the rate of Prematurity with different maternal Vitamin D levels	Prematurity Rate in percentage	Blood samples will be taken from pregnant women up to the 13th week of pregnancy and then at the second collection point up to 48 hours after the birth (after participant enrollment; two collection points)
Primary	Differences in Birth Weight with different maternal Vitamin D levels	Birth Weight in grams	Blood samples will be taken from pregnant women up to the 13th week of pregnancy and then at the second collection point up to 48 hours after the birth (after participant enrollment; two collection points)
Primary	Differences in Apgar Scores with different maternal Vitamin D levels	Apgar Scores in Scale (<7 or =7)	Blood samples will be taken from pregnant women up to the 13th week of pregnancy and then at the second collection point up to 48 hours after the birth (after participant enrollment; two collection points)
Primary	Differences in the number of admissions to the Neonatal Intensive Care Unit with different maternal Vitamin D levels	Number of admissions to the Neonatal Intensive Care Unit in percentage	Blood samples will be taken from pregnant women up to the 13th week of pregnancy and then at the second collection point up to 48 hours after the birth (after participant enrollment; two collection points)
Primary	Differences in the Neonatal Morbidity rate with different maternal Vitamin D levels	Neonatal Morbidity rate in percentage	Blood samples will be taken from pregnant women up to the 13th week of pregnancy and then at the second collection point up to 48 hours after the birth (after participant enrollment; two collection points)
Primary	Differences in the Neonatal Mortality rate with different maternal Vitamin D levels	Neonatal Mortality rate in percentage	Blood samples will be taken from pregnant women up to the 13th week of pregnancy and then at the second collection point up to 48 hours after the birth (after participant enrollment; two collection points)
Primary	Differences in the number of Neonatal Infections with different maternal Vitamin D levels	Number of Neonatal Infections in percentage	Blood samples will be taken from pregnant women up to the 13th week of pregnancy and then at the second collection point up to 48 hours after the birth (after participant enrollment; two collection points)
Primary	Differences in the Number of Congenital Malformation diagnoses with different maternal vitamin D levels	Number of Congenital Malformation diagnoses in percentage	Blood samples will be taken from pregnant women up to the 13th week of pregnancy and then at the second collection point up to 48 hours after the birth (after participant enrollment; two collection points)
Primary	Differences in the presence of vitamin D-related polymorphisms with different maternal levels of vitamin D	Differences will be assessed following the defined outcome indicators related to prematurity	Saliva samples from pregnant women will be collected during admission to the hospital or up to 48 hours after delivery (after participant enrollment; single collection point)
Secondary	Differences in maternal vitamin D levels between the three groups/cohorts related to prematurity		Through study completion, an average of 3 months
Secondary	Differences in maternal vitamin D levels between the three groups/cohorts related to birth weight		Through study completion, an average of 3 months
Secondary	Differences in maternal vitamin D levels between the three groups/cohorts related to Apgar scores		Through study completion, an average of 3 months
Secondary	Differences in maternal vitamin D levels between the three groups/cohorts related to admission to the Neonatal Intensive Care Unit		Through study completion, an average of 3 months
Secondary	Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal morbidity		Through study completion, an average of 3 months
Secondary	Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal mortality		Through study completion, an average of 3 months
Secondary	Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal infections.		Through study completion, an average of 3 months
Secondary	Differences in maternal vitamin D levels between the three groups/cohorts related to the diagnosis of congenital malformations		Through study completion, an average of 3 months
Secondary	Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with prematurity		Through study completion, an average of 3 months
Secondary	Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with birth weight		Through study completion, an average of 3 months
Secondary	Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with Apgar scores		Through study completion, an average of 3 months
Secondary	Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with admission to the Neonatal Intensive Care Unit.		Through study completion, an average of 3 months
Secondary	Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal morbidity		Through study completion, an average of 3 months
Secondary	Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal mortality		Through study completion, an average of 3 months
Secondary	Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal infections		Through study completion, an average of 3 months
Secondary	Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with the diagnosis of congenital malformations		Through study completion, an average of 3 months