Vitamin D in Pregnancy

NCT ID: NCT04291313

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-08
• Study Completion Date: 2023-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

Vitamin D Deficiency; Pre-Eclampsia; Fetal Growth Retardation; Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Current recommended dose of vitamin D

Women in this study arm receive 10 µg of vitamin D3 per day, which is the dose in a standard prenatal multivitamin and the dose currently recommended by the Danish Health Authorities to all pregnant women. They will receive a prenatal vitamin containing 10µg of vitamin D + a placebo supplement.

Group Type: PLACEBO_COMPARATOR

Vitamin D3 (10µg)

Intervention Type: DIETARY_SUPPLEMENT

This intervention serves as a control as they get the current recommended vitamin D dose

Higher dose of vitamin D

Women in this arm receive 90µg of vitamin D3 per day: 10 µg from a standard prenatal multivitamin + an additional supplement containing 80µg of vitamin D3.

Group Type: EXPERIMENTAL

Vitamin D3 (90µg)

Intervention Type: DIETARY_SUPPLEMENT

The intervention is a higher dose of vitamin D than what is currently recommended to Danish pregnant women

Interventions

Vitamin D3 (90µg)

The intervention is a higher dose of vitamin D than what is currently recommended to Danish pregnant women

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3 (10µg)

This intervention serves as a control as they get the current recommended vitamin D dose

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Biomedicine, University of Aarhus

Aarhus, , Denmark

Site Status: ACTIVE_NOT_RECRUITING

Randers Regional Hospital

Randers, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Anna Louise Vestergaard, MD

Role: CONTACT

alv@clin.au.dk

+45 28951794

Facility Contacts

Pinar Bor, MD, PhD

Role: primary

isipinbo@rm.dk

Anna Louise Vestergaard, MD

Role: backup

annavt@rm.dk

References

Vestergaard AL, Christensen M, Andreasen MF, Larsen A, Bor P. Vitamin D in pregnancy (GRAVITD) - a randomised controlled trial identifying associations and mechanisms linking maternal Vitamin D deficiency to placental dysfunction and adverse pregnancy outcomes - study protocol. BMC Pregnancy Childbirth. 2023 Mar 15;23(1):177. doi: 10.1186/s12884-023-05484-x.

Reference Type: DERIVED

PMID: 36922777 (View on PubMed)

Other Identifiers

GRAVITD

Identifier Type: -

Identifier Source: org_study_id