Effects of Vitamin D on Health Promotion During Pregnancy and Its Impact on Prematurity-Related Outcome Indicators in the Alentejo Region
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Differences in the rate of Prematurity with different maternal Vitamin D levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Language barrier (lack of basic understanding of Portuguese).
结局指标
主要结局
Differences in the rate of Prematurity with different maternal Vitamin D levels
时间窗: 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
Differences in the number of admissions to the Neonatal Intensive Care Unit with different maternal Vitamin D levels
时间窗: 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
Differences in the Neonatal Mortality rate with different maternal Vitamin D levels
时间窗: 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
Differences in Apgar Scores with different maternal Vitamin D levels
时间窗: 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)
Differences in the Number of Congenital Malformation diagnoses with different maternal vitamin D levels
时间窗: 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
Differences in the Neonatal Morbidity rate with different maternal Vitamin D levels
时间窗: 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
Differences in the presence of vitamin D-related polymorphisms with different maternal levels of vitamin D
时间窗: 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
Differences in Birth Weight with different maternal Vitamin D levels
时间窗: 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
Differences in the number of Neonatal Infections with different maternal Vitamin D levels
时间窗: 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
次要结局
- 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 infections.(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(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(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(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 the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with prematurity(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.(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(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(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)
- 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 neonatal mortality(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(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(Through study completion, an average of 3 months)
研究者
Maria Olívia Pereira Barbosa
Principal Investigator; MSc; PhD student
University of Évora