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Vitamin D DeficiencyVitDTrackingNCT06292195

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

An observational study of Vitamin D Deficiency and Pregnancy, run by University of Évora at 3 sites in Portugal.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 16 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Vitamin D Deficiency, Pregnancy
What is being tested?
Exposure
How many people
2,000 participants
Where
3 sitesPortugal
Study dates
3 Nov 2023to 30 Jun 2027
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Pregnant women's in the Alentejo region

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Portugal3 sites
  • Unidade Local de Saúde do Baixo Alentejo

    Beja, Beja District, 7801-849

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

    Evora, Évora District, 7000-811

  • Unidade Local de Saúde do Norte Alentejano

    Portalegre, Portalegre District, 7301-853

Other trials in Portugal

About this study

Official title: 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.

Read the 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.

Being tested
Exposure
Keywords
Vitamin D, Pregnancy, Prematurity, Genetic polymorphisms
Medical subject headings
Vitamin D Deficiency, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExposureOther

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

Study groups in NCT06292195
Study groupRoleWhat they receive
Cohort VitDTracking: Group 1- Pregnant women with vitamin D Sufficiency (≥30 ng/mL)Not described
Receives: Other: Exposure
Cohort VitDTracking: Group 2 - Pregnant women with vitamin D Insufficiency (20-29 ng/mL)Not described
Receives: Other: Exposure
Cohort VitDTracking: Group 3 - Pregnant women with vitamin D Deficiency (<20 ng/mL)Not described
Receives: Other: Exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences in the rate of Prematurity with different maternal Vitamin D levels

    Prematurity Rate in percentage

    Measured: 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)

  2. Differences in Birth Weight with different maternal Vitamin D levels

    Birth Weight in grams

    Measured: 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)

  3. Differences in Apgar Scores with different maternal Vitamin D levels

    Apgar Scores in Scale (<7 or ≥7)

    Measured: 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)

  4. 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

    Measured: 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)

  5. Differences in the Neonatal Morbidity rate with different maternal Vitamin D levels

    Neonatal Morbidity rate in percentage

    Measured: 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)

  6. Differences in the Neonatal Mortality rate with different maternal Vitamin D levels

    Neonatal Mortality rate in percentage

    Measured: 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)

  7. Differences in the number of Neonatal Infections with different maternal Vitamin D levels

    Number of Neonatal Infections in percentage

    Measured: 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)

  8. Differences in the Number of Congenital Malformation diagnoses with different maternal vitamin D levels

    Number of Congenital Malformation diagnoses in percentage

    Measured: 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)

  9. 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

    Measured: 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)
  1. Differences in maternal vitamin D levels between the three groups/cohorts related to prematurity

    Measured: Through study completion, an average of 3 months

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

    Measured: Through study completion, an average of 3 months

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

    Measured: Through study completion, an average of 3 months

  4. Differences in maternal vitamin D levels between the three groups/cohorts related to admission to the Neonatal Intensive Care Unit

    Measured: Through study completion, an average of 3 months

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

    Measured: Through study completion, an average of 3 months

  6. Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal mortality

    Measured: Through study completion, an average of 3 months

  7. Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal infections.

    Measured: Through study completion, an average of 3 months

  8. Differences in maternal vitamin D levels between the three groups/cohorts related to the diagnosis of congenital malformations

    Measured: Through study completion, an average of 3 months

  9. Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with prematurity

    Measured: Through study completion, an average of 3 months

  10. Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with birth weight

    Measured: Through study completion, an average of 3 months

  11. Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with Apgar scores

    Measured: Through study completion, an average of 3 months

  12. Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with admission to the Neonatal Intensive Care Unit.

    Measured: Through study completion, an average of 3 months

  13. Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal morbidity

    Measured: Through study completion, an average of 3 months

  14. Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal mortality

    Measured: Through study completion, an average of 3 months

  15. Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal infections

    Measured: Through study completion, an average of 3 months

  16. Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with the diagnosis of congenital malformations

    Measured: Through study completion, an average of 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2024
  2. Study start3 Nov 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06292195
Sponsor's protocol ID
VitDTracking
Acronym
VitDTracking
Status last verified
Mar 2026
First submitted
19 Feb 2024
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40218918

Questions about this trial

What is this clinical trial studying?

An observational study of Vitamin D Deficiency and Pregnancy, run by University of Évora at 3 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06292195, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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