Next-generation Effects of Vitamin D Supplementation in Pregnancy

University of Aarhus

Status: Not yet enrolling

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

Treatments: Other: Intrauterine 10µg D-vitamin; Other: Intrauterine 90µg D-vitamin

Study type: Observational

Funder types: Other

Identifiers

NCT05616117

01092022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: Under 15 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

High-dose intrauterine D3-vitamin

Description:

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

Treatment:

Other: Intrauterine 90µg D-vitamin

Low-dose intrauterine D3-vitamin

Description:

Children of mothers who received 10 µg vitamin D3 daily during pregnancy from 12 weeks to delivery

Treatment:

Other: Intrauterine 10µg D-vitamin