Clinical trial NCT05616117: Next-generation Effects of Vitamin D Supplementation in Pregnancy
Official title: Next-generation Effects of Vitamin D Supplementation in Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Growth
Vitamin D Supplementation
Immune System Diseases
Child Development
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 600
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children born to mothers participated in our previous RCT (NCT04291313)

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.

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

Primary outcomes:
measure: Growth of child
timeFrame: From birth to 11-13 month of age
measure: Immune cell function
timeFrame: From birth to 11-13 month of age
Secondary outcomes:
measure: Well-being and developmental scores
timeFrame: At birth and at 11-13 month of age
measure: Hospital contact
timeFrame: At birth to 11-13 month of age
measure: Parent reported infections
timeFrame: At birth to 11-13 month of age
measure: Colic
timeFrame: At birth to 11-13 month of age
measure: Medicine use
timeFrame: At birth to 11-13 month of age
measure: Scanning of the anterior fontanelle
timeFrame: At 11-13 month of age.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Obstetrics and Gynaecology, Regional Hospital Randers
name: Pinar Bor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: