Vitamin D in Pregnancy

NCT04291313 | Unknown DMC

• 1 other identifier: GRAVITD
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• The prevalence of pre-eclampsia (PE)

  The effect of 90 μg on the prevalence of PE

  From 20 weeks of gestation to delivery

• The prevalence of fetal growth retardation (FGR)

  The effect of 90 μg on the prevalence of FGR

  From 20 weeks of gestation to delivery

• The prevalence of gestational diabetes (GDM)

  The effect of 90 μg on the prevalence of GDM

  From 20 weeks of gestation to delivery

Secondary Outcomes (11)

• 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

• 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

• Birthweight

  At delivery

• Size related to gestational age

  At delivery

• The prevalence of preterm birth

  At delivery

Study Arms (2)

Current recommended dose of vitamin D

PLACEBO COMPARATOR

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.

Dietary Supplement: Vitamin D3 (10µg)

Higher dose of vitamin D

EXPERIMENTAL

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.

Dietary Supplement: Vitamin D3 (90µg)

Interventions

Vitamin D3 (90µg) DIETARY_SUPPLEMENT

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

Higher dose of vitamin D

Vitamin D3 (10µg) DIETARY_SUPPLEMENT

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

Current recommended dose of vitamin D

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (2)

Department of Biomedicine, University of Aarhus

Aarhus, DK-8000, Denmark

ACTIVE NOT RECRUITING

Randers Regional Hospital

Randers, DK-8930, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 36922777 DERIVED

MeSH Terms

Conditions

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

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Anna Louise Vestergaard, MD

CONTACT

+45 28951794; alv@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: March 2, 2020
• Study Start: June 8, 2020
• Primary Completion: February 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

DK (2)