Clinical trial NCT06292195: Effects of Vitamin D on Health Promotion During Pregnancy and Its Impact on Prematurity-Related Outcome
Official title: Effects of Vitamin D on Health Promotion During Pregnancy and Its Impact on Prematurity-Related Outcome Indicators in the Alentejo Region
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vitamin D Deficiency
Pregnancy
Keywords: Vitamin D
Pregnancy
Prematurity
Genetic polymorphisms
Lead sponsor: University of Évora
Sponsor class: OTHER
Collaborators: name: Comprehensive Health Research Center
name: Unidade Local De Saúde Do Norte Alentejano
name: Unidade local de Saúde do Baixo Alentejano
name: Unidade Local de Saúde do Alentejo Central
name: Universidade Nova de Lisboa
name: Instituto de Engenharia de Sistemas e Computadores - Inovação e Desenvolvimento de Lisboa (INESC-ID)
First posted: 2024-03-05
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women's in the Alentejo region

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Differences in the rate of Prematurity with different maternal Vitamin D levels
timeFrame: 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)
measure: Differences in Birth Weight with different maternal Vitamin D levels
timeFrame: 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)
measure: Differences in Apgar Scores with different maternal Vitamin D levels
timeFrame: 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)
measure: Differences in the number of admissions to the Neonatal Intensive Care Unit with different maternal Vitamin D levels
timeFrame: 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)
measure: Differences in the Neonatal Morbidity rate with different maternal Vitamin D levels
timeFrame: 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)
measure: Differences in the Neonatal Mortality rate with different maternal Vitamin D levels
timeFrame: 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)
measure: Differences in the number of Neonatal Infections with different maternal Vitamin D levels
timeFrame: 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)
measure: Differences in the Number of Congenital Malformation diagnoses with different maternal vitamin D levels
timeFrame: 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)
measure: Differences in the presence of vitamin D-related polymorphisms with different maternal levels of vitamin D
timeFrame: 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 outcomes:
measure: Differences in maternal vitamin D levels between the three groups/cohorts related to prematurity
timeFrame: Through study completion, an average of 3 months
measure: Differences in maternal vitamin D levels between the three groups/cohorts related to birth weight
timeFrame: Through study completion, an average of 3 months
measure: Differences in maternal vitamin D levels between the three groups/cohorts related to Apgar scores
timeFrame: Through study completion, an average of 3 months
measure: Differences in maternal vitamin D levels between the three groups/cohorts related to admission to the Neonatal Intensive Care Unit
timeFrame: Through study completion, an average of 3 months
measure: Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal morbidity
timeFrame: Through study completion, an average of 3 months
measure: Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal mortality
timeFrame: Through study completion, an average of 3 months
measure: Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal infections.
timeFrame: Through study completion, an average of 3 months
measure: Differences in maternal vitamin D levels between the three groups/cohorts related to the diagnosis of congenital malformations
timeFrame: Through study completion, an average of 3 months
measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with prematurity
timeFrame: Through study completion, an average of 3 months
measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with birth weight
timeFrame: Through study completion, an average of 3 months
measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with Apgar scores
timeFrame: Through study completion, an average of 3 months
measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with admission to the Neonatal Intensive Care Unit.
timeFrame: Through study completion, an average of 3 months
measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal morbidity
timeFrame: Through study completion, an average of 3 months
measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal mortality
timeFrame: Through study completion, an average of 3 months
measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal infections
timeFrame: Through study completion, an average of 3 months
measure: Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with the diagnosis of congenital malformations
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Beja
country: Portugal
facility: Unidade Local de Saúde do Baixo Alentejo
city: Portalegre
country: Portugal
facility: Unidade Local de Saúde do Norte Alentejano
city: Évora
country: Portugal
facility: Unidade Local de Saúde do Alentejo Central - Hospital Espirito Santo de Évora
Study officials:
affiliation: University of Évora
name: Maria OP Barbosa, MSc; PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Évora
name: Dulce Cruz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Nova de Lisboa
name: André Rosário, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Nova de Lisboa
name: Marta Silvestre, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Engenharia de Sistemas e Computadores - Inovação e Desenvolvimento de Lisboa (INESC-ID)
name: Ana T Freitas, PhD
role: PRINCIPAL_INVESTIGATOR
References: