Next-generation Effects of Vitamin D Supplementation in Pregnancy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Growth of child [From birth to 11-13 month of age]
The growth from birth to the clinical examination at 11-13 month of age
- Immune cell function [From birth to 11-13 month of age]
The immune cell function at birth and at 11-13 month of age.
Secondary Outcome Measures
- Well-being and developmental scores [At birth and at 11-13 month of age]
ASQ-3 scores and parent-reported well-being of the children at 11-13 month of age.
- Hospital contact [At birth to 11-13 month of age]
Number of hospital contacts during the first year
- Parent reported infections [At birth to 11-13 month of age]
Number of infections during the first year of life
- Colic [At birth to 11-13 month of age]
Does the child have colic
- Medicine use [At birth to 11-13 month of age]
Parent reported use of medicine, incl. astma-medicine and movicol.
- Scanning of the anterior fontanelle [At 11-13 month of age.]
Ultrasound-scan of the anterior fontanelle
Eligibility Criteria
Criteria
Inclusion Criteria:
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Born by mother from our previous RCT (NCT04291313)
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All with parental authority have given consent for inclusion
Exclusion Criteria:
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Mother with compliance <80% to study drug
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Mother has denied further contact in this follow-up study
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Aarhus
Investigators
- Principal Investigator: Pinar Bor, MD, PhD, Department of Obstetrics and Gynaecology, Regional Hospital Randers
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 01092022