Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05616117 |
Other study ID # |
01092022 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.