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临床试验/NCT03330301
NCT03330301已完成不适用

D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life

Bispebjerg Hospital1 个研究点 分布在 1 个国家目标入组 222,776 人开始时间: 2012年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
222,776
试验地点
1
主要终点
Pre-eclampsia

研究概览

简要总结

Vitamin D deficiency is common among otherwise healthy pregnant women and may have consequences for them as well as the early development and long-term health of their children. However, the importance of maternal vitamin D status has not been widely studied.

The present study is divided into a societal experiment (1) and a case-cohort study (2):

  1. The present study includes an in-depth examination of the influence of exposure to vitamin D early in life and during critical periods of growth for development of type 1 diabetes (T1D), type 2 diabetes, gestational diabetes, pre-eclampsia, obesity, asthma, arthritis, cancer, mental and cognitive disorders, congenital disorders, dental caries and bone fractures during child- and adulthood. The study is based on the fact that mandatory fortification of margarine with vitamin D, which initiated in 1937, was terminated in 1985.

Apart from determining the influences of exposure prior to conception and during pre- and postnatal life, the investigators examined the importance of vitamin D exposure during specific seasons and trimesters, by comparing disease incidence among individuals born before and after the fortification. 2. Additionally, a validated method was used to determine neonatal vitamin D status using stored dried blood spots (DBS) from individuals who develop the aforementioned disease entities as adults and their time and gender-matched controls.

Unparalleled, the study will help determine the effects of vitamin D exposure during critical periods in life. There are a sufficient number of individuals to verify any effects during different gestation phases and seasons of the year. The results, which will change our current understanding of the significance of vitamin D, will enable new research in related fields, including interventional research designed to assess supplementation needs for different subgroups of pregnant women. Also, other health outcomes can subsequently be studied to generate multiple new interdisciplinary health research opportunities involving vitamin D.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Born in Denmark around the fortification period
  • Sufficient amount of blood from the DBS

排除标准

  • 1.Born outside Denmark
  • Born outside the fortification period
  • Insufficient amount of blood from the DBS or DBS not found

结局指标

主要结局

Pre-eclampsia

时间窗: 2012-2025

Register based

Bone facture

时间窗: 2012-2025

Register based

Obesity

时间窗: 2012-2025

Register based

Type 1 diabetes

时间窗: 2012-2016

Register based

次要结局

  • Type 2 diabetes(2014-2025)
  • Arthritis(2018-2025)
  • Asthma(2015-2025)
  • Birth weight(2014-2019)
  • Mental diseases(2012-2025)
  • Gestational diabetes(2014-2025)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Berit Lilienthal Heitmann

Professor

Bispebjerg Hospital

研究点 (1)

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