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临床试验/NCT05616117
NCT05616117尚未招募不适用

Next-generation Effects of Vitamin D Supplementation in Pregnancy

University of Aarhus0 个研究点目标入组 600 人开始时间: 2022年11月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
600
主要终点
Immune cell function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 15 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Born by mother from our previous RCT (NCT04291313)
  • All with parental authority have given consent for inclusion

排除标准

  • Mother with compliance <80% to study drug
  • Mother has denied further contact in this follow-up study

结局指标

主要结局

Immune cell function

时间窗: From birth to 11-13 month of age

The immune cell function at birth and at 11-13 month of age.

Growth of child

时间窗: From birth to 11-13 month of age

The growth from birth to the clinical examination at 11-13 month of age

次要结局

  • Parent reported infections(At birth to 11-13 month of age)
  • Colic(At birth to 11-13 month of age)
  • Scanning of the anterior fontanelle(At 11-13 month of age.)
  • Well-being and developmental scores(At birth and at 11-13 month of age)
  • Hospital contact(At birth to 11-13 month of age)
  • Medicine use(At birth to 11-13 month of age)

研究者

申办方类型
Other
责任方
Sponsor

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