Vitamin D in Pregnancy

  • STATUS
    Recruiting
  • End date
    May 6, 2023
  • participants needed
    2000
  • sponsor
    University of Aarhus
Updated on 6 May 2021

Summary

Danish pregnant women are recommended ad daily vitamin D supplement of 10 g. 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 90g/day can reduce the prevalence of placenta-related pregnancy complications. Combining a double-blinded randomized trial (10g vs.90g) 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.

Description

As vitamin D (vit-D) is essential for growth and linked to placental function, health authorities recommend a daily 10g 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, todays 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 g 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 g 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.

Details
Condition Gestational Diabetes, Diabetes Mellitus, Diabetes Mellitus Types I and II, Diabetes Prevention, Diabetes (Pediatric), Vitamin D Deficiency, Intrauterine Growth Retardation, Pre-Eclampsia, Preeclampsia, Vitamin Deficiency, Vitamin Deficiency, Pregnancy Complications, Pregnancy Complications, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Preeclampsia, iugr, fetal growth restriction, fetal growth retardation, intrauterine growth restriction, toxemia of pregnancy
Treatment Vitamin D3 (90µg), Vitamin D3 (10µg)
Clinical Study IdentifierNCT04291313
SponsorUniversity of Aarhus
Last Modified on6 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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