Next-generation Effects of Vitamin D Supplementation in Pregnancy
- Conditions
- Immune System DiseasesGrowthVitamin D SupplementationChild Development
- Interventions
- Other: Intrauterine 90µg D-vitaminOther: Intrauterine 10µg D-vitamin
- Registration Number
- NCT05616117
- Lead Sponsor
- University of Aarhus
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 600
- Born by mother from our previous RCT (NCT04291313)
- All with parental authority have given consent for inclusion
- Mother with compliance <80% to study drug
- Mother has denied further contact in this follow-up study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description High-dose intrauterine D3-vitamin Intrauterine 90µg D-vitamin Children of mothers who received 90 µg vitamin D3 daily during pregnancy from 12 weeks to delivery. Low-dose intrauterine D3-vitamin Intrauterine 10µg D-vitamin Children of mothers who received 10 µg vitamin D3 daily during pregnancy from 12 weeks to delivery
- Primary Outcome Measures
Name Time Method Immune cell function From birth to 11-13 month of age The immune cell function at birth and at 11-13 month of age.
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
- Secondary Outcome Measures
Name Time Method Medicine use At birth to 11-13 month of age Parent reported use of medicine, incl. astma-medicine and movicol.
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
Scanning of the anterior fontanelle At 11-13 month of age. Ultrasound-scan of the anterior fontanelle
Hospital contact At birth to 11-13 month of age Number of hospital contacts during the first year
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.