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Vitamin D in Pregnancy

NCT04291313 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2021-04-28

No results posted yet for this study

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

Vitamin D3 (90µg)

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

DIETARY_SUPPLEMENT

Vitamin D3 (10µg)

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

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-08
Primary Completion
2023-02-28
Completion
2023-05-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04291313 on ClinicalTrials.gov