Next-generation Effects of Vitamin D Supplementation in Pregnancy

NCT ID: NCT05616117

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2024-11-30

Brief Summary

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.

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.

Conditions

Growth; Vitamin D Supplementation; Immune System Diseases; Child Development

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

High-dose intrauterine D3-vitamin

Children of mothers who received 90 µg vitamin D3 daily during pregnancy from 12 weeks to delivery.

Intrauterine 90µg D-vitamin

Intervention Type: OTHER

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

Intrauterine 10µg D-vitamin

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 15 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pinar Bor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynaecology, Regional Hospital Randers

Central Contacts

Pinar Bor, MD, PhD

Role: CONTACT

isipinbo@rm.dk

+4522504767

Other Identifiers

01092022

Identifier Type: -

Identifier Source: org_study_id