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临床试验/NCT04291313
NCT04291313Unknown不适用

Vitamin D Deficiency in Pregnancy - Identifying Associations and Mechanisms Linking Maternal Vitamin D Deficiency to Placental Dysfunction and Adverse Pregnancy Outcomes

University of Aarhus4 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2020年6月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
4
主要终点
The prevalence of pre-eclampsia (PE)

研究概览

简要总结

Danish pregnant women are recommended ad daily vitamin D supplement of 10 µg. Despite the fact that 9 out of 10 women take vitamin D supplements, more than 40% of pregnant women are vitamin D deficient, putting them at an increased risk of pregnancy complications like fetal growth restriction and pre-eclampsia. Our hypothesis is that pregnant women would benefit from an increased intake og vitamin D and that an intake of 90µg/day can reduce the prevalence of placenta-related pregnancy complications. Combining a double-blinded randomized trial (10µg vs.90µg) with collection of placental material, we want to test if the prevalence of pregnancy complications is reduced and explore how vitamin D affects placenta to improve our understanding of the disease pathology and risk factors.

详细描述

As vitamin D (vit-D) is essential for growth and linked to placental function, health authorities recommend a daily 10µg vit-D supplement in pregnancy. Despite the fact that 9 out of 10 women take supplements, more than 40% of pregnant women are vit-D deficient, putting them at an increased risk of pregnancy complications like fetal growth restriction and pre-eclampsia. These conditions affect 6-10 % of all pregnancies, increasing the risk of preterm delivery, perinatal morbidity and mortality. In worse case, preeclampsia may also be fatal for the pregnant women herself. Around 20% of vit-D intake comes from the diet (e.g. fish, egg yolk) and the rest from sun-exposure. However, in Denmark, there is not enough sunlight from October to March to fuel vit-D synthesis underlining the need for supplementation. The high prevalence of vit-D deficiency indicates that current guidelines are not sufficient. Indeed, today´s recommendations date back to a small-scale 1986 Norwegian study not taking into account dietary differences such as the high intake of fish in Norway. Since then, accumulating evidence has linked exposure to pregnancy complications and vit-D deficiency per see to long-term health problems in the affected children. This include a higher risk of asthma, cardiovascular disease, diabetes, obesity schizophrenia, neurodevelopmental problems and multiple sclerosis. Notably, the affected women also suffer an increased risk of disease, e.g. heart disease in later life. Vitamin D supplements in the range of 90-100 µg are safe in pregnancy, but it is not yet known if and to what extent increased vitamin D supplementation prevents pregnancy-related diseases. Combining clinical testing of 90 µg vitamin D supplements, with identification of which placental pathways that are affected by vit-D would considerably improve our understanding of disease pathophysiology and the role of vit-D and improve the health of future generations in an easily implementable way.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

盲法说明

Treatment is blinded for participants and for the caretakers including nurses, midwifes and obstetricians.

The investigators do not participate in diagnosing patients and are not blinded.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • All pregnant women attending the nuchal translucency scan in week 11-13 of gestation as part of the national prenatal screening program

排除标准

  • Age< 18 years
  • Women with calcium metabolism disorders,
  • Women who gets doctor prescribed vitamin D treatment
  • Women with chronic kidney disease

结局指标

主要结局

The prevalence of pre-eclampsia (PE)

时间窗: From 20 weeks of gestation to delivery

The effect of 90 μg on the prevalence of PE

The prevalence of fetal growth retardation (FGR)

时间窗: From 20 weeks of gestation to delivery

The effect of 90 μg on the prevalence of FGR

The prevalence of gestational diabetes (GDM)

时间窗: From 20 weeks of gestation to delivery

The effect of 90 μg on the prevalence of GDM

次要结局

  • Changes in the placental expression of genes- and proteins related to vitamin D, evaluated using Next Generation Sequencing (NGS), quantitative Polymerase Chain Reaction (qPCR), methylation (Bisulfite conversion) and western blotting.(At delivery)
  • Birthweight(At delivery)
  • Size related to gestational age(At delivery)
  • The prevalence of preterm birth(At delivery)
  • Mode of delivery(At delivery)
  • The prevalence of postterm birth(At delivery)
  • The prevalence of gestational hypertension(From 20 weeks of gestation to delivery)
  • Changes in the placental expression of genes- and proteins related to vitamin D and the pathogenesis of PE, FGR and GDM in placental tissue from complicated pregnancies compared to uncomplicated pregnancies, evaluated using NGS, qPCR and western blotting(At delivery)
  • The prevalence of infection during delivery(At delivery)
  • Prevalence of post partum hemorrhage > 500 ml(The first 24 hours after delivery)
  • Admission to the neonatal ward(The first two weeks after birth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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