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

March 2, 2024 updated by: Maria Olívia Pereira Barbosa, University of Évora

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dulce Cruz, PhD
  • Phone Number: 00351969106244
  • Email: dcruz@uevora.pt

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women's in the Alentejo region

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort VitDTracking: Group 1- Pregnant women with vitamin D Sufficiency (≥30 ng/mL)
Other: 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)
Other: 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)
Other: Exposure
Maternal vitamin D levels during pregnancy (serum 25-hydroxyvitamin D levels)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in the rate of Prematurity with different maternal Vitamin D levels
Time Frame: 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)
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)
Differences in Birth Weight with different maternal Vitamin D levels
Time Frame: 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)
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)
Differences in Apgar Scores with different maternal Vitamin D levels
Time Frame: 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)
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)
Differences in the number of admissions to the Neonatal Intensive Care Unit with different maternal Vitamin D levels
Time Frame: 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)
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)
Differences in the Neonatal Morbidity rate with different maternal Vitamin D levels
Time Frame: 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)
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)
Differences in the Neonatal Mortality rate with different maternal Vitamin D levels
Time Frame: 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)
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)
Differences in the number of Neonatal Infections with different maternal Vitamin D levels
Time Frame: 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)
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)
Differences in the Number of Congenital Malformation diagnoses with different maternal vitamin D levels
Time Frame: 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)
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)
Differences in the presence of vitamin D-related polymorphisms with different maternal levels of vitamin D
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Time Frame
Differences in maternal vitamin D levels between the three groups/cohorts related to prematurity
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Differences in maternal vitamin D levels between the three groups/cohorts related to birth weight
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Differences in maternal vitamin D levels between the three groups/cohorts related to Apgar scores
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Differences in maternal vitamin D levels between the three groups/cohorts related to admission to the Neonatal Intensive Care Unit
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal morbidity
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal mortality
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal infections.
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Differences in maternal vitamin D levels between the three groups/cohorts related to the diagnosis of congenital malformations
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with prematurity
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with birth weight
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with Apgar scores
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with admission to the Neonatal Intensive Care Unit.
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal morbidity
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal mortality
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal infections
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months
Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with the diagnosis of congenital malformations
Time Frame: Through study completion, an average of 3 months
Through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Évora

Collaborators

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

Investigators

  • Principal Investigator: Maria OP Barbosa, MSc; PhD student, University of Évora
  • Principal Investigator: Dulce Cruz, PhD, University of Évora
  • Principal Investigator: André Rosário, PhD, Universidade Nova de Lisboa
  • Principal Investigator: Marta Silvestre, PhD, Universidade Nova de Lisboa
  • Principal Investigator: Ana T Freitas, PhD, Instituto de Engenharia de Sistemas e Computadores - Inovação e Desenvolvimento de Lisboa (INESC-ID)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

March 2, 2024

First Posted (Estimated)

March 5, 2024

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 2, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VitDTracking

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin D Deficiency

Clinical Trials on Exposure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe