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

Bispebjerg Hospital

Status: Completed

Conditions: Congenital Disorders; Vitamin D Deficiency; Diabetes Mellitus; Obesity; Cancer; Birth Disorder; Bone Fracture; Tooth Diseases; Pre-Eclampsia; Mental Disorder; Pregnancy Complications; Birth Weight; Asthma; Arthritis

Treatments: Other: D-tect

Study type: Observational

Funder types: Other

Identifiers

NCT03330301

0603-00453B

Details and patient eligibility

About

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.

Enrollment: 222,776 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Born in Denmark around the fortification period
2. Sufficient amount of blood from the DBS

Exclusion criteria

1.Born outside Denmark

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

Trial design

222,776 participants in 2 patient groups

Exposed

Description:

1. Individuals born between June1983 and May1985 were exposed to the mandatory vitamin D margarine fortification during fetal life. 2. Cases: individuals defined as having one of the aforementioned diseases of interest from the registers

Treatment:

Other: D-tect

Non-exposed

Description:

1. Individuals born between September1986 and August 1988 were not exposed to the mandatory vitamin D margarine fortification during fetal life. 2. Controls: cohort of matched disease-free individuals

Treatment:

Other: D-tect