Clinical trial NCT03330301: D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life
Official title: D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Obesity
Diabetes Mellitus
Pre-Eclampsia
Arthritis
Asthma
Bone Fracture
Tooth Diseases
Birth Weight
Birth Disorder
Pregnancy Complications
Mental Disorder
Cancer
Congenital Disorders
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Council for Strategic Research
First posted: 2017-11-06
Enrollment: 222776
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Entire Danish population born between June1983-May1985 and September 1986-August 1988.

For the part of the study using vitamin D measurements from DBS:

The Danish Civil registration system was used to identify all live-born children during 1981-2002 (n = 1,360,466), and a random subcohort thereof was sampled for 25(OH)D analyses to be used across the D-tect studies (n = 3585)

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Obesity
timeFrame: 2012-2025
measure: Type 1 diabetes
timeFrame: 2012-2016
measure: Pre-eclampsia
timeFrame: 2012-2025
measure: Bone facture
timeFrame: 2012-2025
Secondary outcomes:
measure: Type 2 diabetes
timeFrame: 2014-2025
measure: Gestational diabetes
timeFrame: 2014-2025
measure: Asthma
timeFrame: 2015-2025
measure: Arthritis
timeFrame: 2018-2025
measure: Birth weight
timeFrame: 2014-2019
measure: Mental diseases
timeFrame: 2012-2025
Other outcomes:
measure: Cancers
timeFrame: 2018-2025
measure: Mental disorders
timeFrame: 2018-2025
measure: Dental caries
timeFrame: 2018-2025
measure: Congenital disorders
timeFrame: 2018-2025
Locations:
city: Frederiksberg
country: Denmark
facility: Parker Institute
Study officials:
References:
citation: Keller A, Stougard M, Frederiksen P, Thorsteinsdottir F, Vaag A, Damm P, Jacobsen R, L Heitmann B. In utero exposure to extra vitamin D from food fortification and the risk of subsequent development of gestational diabetes: the D-tect study. Nutr J. 2018 Nov 2;17(1):100. doi: 10.1186/s12937-018-0403-5.