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

NCT06292195 | Recruiting

• 1 other identifier: VitDTracking
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Vitamin D Deficiency; Pregnancy

Keywords

Vitamin D; Pregnancy; Prematurity; Genetic polymorphisms

Outcome Measures

Primary Outcomes (9)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (16)

• Differences in maternal vitamin D levels between the three groups/cohorts related to prematurity

  Through study completion, an average of 3 months

• Differences in maternal vitamin D levels between the three groups/cohorts related to birth weight

  Through study completion, an average of 3 months

• Differences in maternal vitamin D levels between the three groups/cohorts related to Apgar scores

  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

  Through study completion, an average of 3 months

• Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal morbidity

  Through study completion, an average of 3 months

Study Arms (3)

Cohort VitDTracking: Group 1- Pregnant women with vitamin D Sufficiency (≥30 ng/mL)

Other: Exposure

Cohort VitDTracking: Group 2 - Pregnant women with vitamin D Insufficiency (20-29 ng/mL)

Other: Exposure

Cohort VitDTracking: Group 3 - Pregnant women with vitamin D Deficiency (<20 ng/mL)

Other: Exposure

Interventions

Exposure OTHER

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

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)

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Pregnant women's in the Alentejo region
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women's in the Alentejo region

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Évora: lead
• Comprehensive Health Research Center: collaborator
• Unidade Local De Saúde Do Norte Alentejano: collaborator
• Unidade local de Saúde do Baixo Alentejano: collaborator
• Unidade Local de Saúde do Alentejo Central: collaborator
• Universidade Nova de Lisboa: collaborator
• Instituto de Engenharia de Sistemas e Computadores - Inovação e Desenvolvimento de Lisboa (INESC-ID): collaborator

Study Sites (3)

Unidade Local de Saúde do Baixo Alentejo

Beja, 7801-849, Portugal

RECRUITING

Unidade Local de Saúde do Alentejo Central - Hospital Espirito Santo de Évora

Evora, 7000-811, Portugal

RECRUITING

Unidade Local de Saúde do Norte Alentejano

Portalegre, 7301-853, Portugal

RECRUITING

Related Publications (1)

• Barbosa O, Freitas AT, Silvestre MP, Moreira-Rosario A, Aguiar P, Regua AI, Madaleno T, Almeida M, Cruz D. Effects of Maternal Vitamin D Levels on Prematurity: Feasibility Study in a Multicenter Observational Pilot. Nutrients. 2025 Mar 27;17(7):1160. doi: 10.3390/nu17071160.

  PMID: 40218918 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Premature Birth

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria OP Barbosa, MSc; PhD student

CONTACT

00351966056178; d52901@alunos.uevora.pt

Dulce Cruz, PhD

CONTACT

00351969106244; dcruz@uevora.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; MSc; PhD student

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 5, 2024
• Study Start: November 3, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (3)