Next-generation Effects of Vitamin D Supplementation in Pregnancy

Vitamin D deficiency is common among pregnant women, despite daily vitamin D supplements. This study aims to investigate if maternal vitamin D intake of 90 vs 10 µg affects the overall health, growth, and immune system of the offspring at birth and after 1 year. Blood samples at birth and after one year, questionnaires and clinical 1-year examination will be performed on the children.

Study Overview

• Status: Not yet recruiting
• Conditions: Immune System Diseases; Growth; Child Development; Vitamin D Supplementation
• Intervention / Treatment: Other: Intrauterine 90µg D-vitamin; Other: Intrauterine 10µg D-vitamin

Detailed Description

Vitamin D deficiency is common among Danish pregnant women, although most pregnant women adhere to guidelines of a daily supplement of 10 µg vitamin D. Vitamin D deficiency increases the risk of complications in the pregnancy e.g., preeclampsia, gestational diabetes mellitus and fetal growth retardation. Several studies indicate that the offspring has an increased risk of immune diseases e.g., asthma and autoimmune related diseases e.g., multiple sclerosis if the mother had vitamin D deficiency during the pregnancy. It is well known that vitamin D affects the immune system, which raises the question of the effects of vitamin D supplements and which doses to give optimally.

This study aims to investigate if maternal vitamin D intake of 90 vs 10 µg D3 affects the overall health, growth, and immune system of the offspring at birth and after 1 year. Blood samples at birth and after 1 year, questionnaires and clinical 1-year examination will be performed on the children. The hypothesis is that increased vitamin D supplementation in pregnancy improves fetal development including the offspring's immune system and the developing brain. The effects of vitamin D supplementation will strengthen the offspring's overall health at birth and during their first year of life. Hopefully, this can, in the future, be part of a guideline to which dose of vitamin D is recommended for Danish pregnant women.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Pinar Bor, MD, PhD; Phone Number: +4522504767; Email: isipinbo@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children born to mothers participated in our previous RCT (NCT04291313)

Description

Inclusion Criteria:

• Born by mother from our previous RCT (NCT04291313)
• All with parental authority have given consent for inclusion

Exclusion Criteria:

• Mother with compliance <80% to study drug
• Mother has denied further contact in this follow-up study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High-dose intrauterine D3-vitamin; Children of mothers who received 90 µg vitamin D3 daily during pregnancy from 12 weeks to delivery.	Other: Intrauterine 90µg D-vitamin; Children of mothers who received 90 µg vitamin D3 daily during pregnancy:10 µg from a standard prenatal multivitamin + an additional supplement containing 80µg of vitamin D3
Low-dose intrauterine D3-vitamin; Children of mothers who received 10 µg vitamin D3 daily during pregnancy from 12 weeks to delivery	Other: Intrauterine 10µg D-vitamin; Children of mothers who received 10 µg vitamin D3 daily during pregnancy, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth of child	The growth from birth to the clinical examination at 11-13 month of age	From birth to 11-13 month of age
Immune cell function	The immune cell function at birth and at 11-13 month of age.	From birth to 11-13 month of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Well-being and developmental scores	ASQ-3 scores and parent-reported well-being of the children at 11-13 month of age.	At birth and at 11-13 month of age
Hospital contact	Number of hospital contacts during the first year	At birth to 11-13 month of age
Parent reported infections	Number of infections during the first year of life	At birth to 11-13 month of age
Colic	Does the child have colic	At birth to 11-13 month of age
Medicine use	Parent reported use of medicine, incl. astma-medicine and movicol.	At birth to 11-13 month of age
Scanning of the anterior fontanelle	Ultrasound-scan of the anterior fontanelle	At 11-13 month of age.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Pinar Bor, MD, PhD, Department of Obstetrics and Gynaecology, Regional Hospital Randers

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Vitamin D; Vitamins
• Other Study ID Numbers: 01092022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No