Next-generation Effects of Vitamin D Supplementation in Pregnancy
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
- 是
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)
