Next-generation Effects of Vitamin D Supplementation in Pregnancy

Child Development Clinical Trial

Official title:

Next-generation Effects of Vitamin D Supplementation in Pregnancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05616117
• Other study ID #: 01092022
• Status: Not yet recruiting
• Start date: November 2022
• Est. completion date: November 2024

Study information

• Verified date: October 2022
• Source: University of Aarhus
• Contact: Pinar Bor, MD, PhD
• Phone: +4522504767
• Email: isipinbo[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 15 Months

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Hospital contact	Number of hospital contacts during the first year	At birth to 11-13 month of age
Secondary	Parent reported infections	Number of infections during the first year of life	At birth to 11-13 month of age
Secondary	Colic	Does the child have colic	At birth to 11-13 month of age
Secondary	Medicine use	Parent reported use of medicine, incl. astma-medicine and movicol.	At birth to 11-13 month of age
Secondary	Scanning of the anterior fontanelle	Ultrasound-scan of the anterior fontanelle	At 11-13 month of age.