D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life
NCT ID: NCT03330301
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
222776 participants
OBSERVATIONAL
2012-04-01
2016-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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Exposed
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
D-tect
1. This study is based on a unique Danish social experiment that took place during a well-defined period between 1937 and December 1985, when it was mandatory to fortify all margarine with vitamin D (1.25 μg/100 g). This well-defined vitamin D fortification period makes it possible to investigate the impact of fetal exposure to extra vitamin D from food fortification on the risk of developing diseases later on. This study is possible due not only to the well-defined adjacent time window but also to the complete registration of every citizen via a civil registration number. This number can be linked, on an individual level, to Danish birth, patient and medical registries; social and ethnic registries; and clinical and other large databases
2. Case-cohort study: vitamin D measurements from dried blood spots and the risk of diseases later on
Non-exposed
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
D-tect
1. This study is based on a unique Danish social experiment that took place during a well-defined period between 1937 and December 1985, when it was mandatory to fortify all margarine with vitamin D (1.25 μg/100 g). This well-defined vitamin D fortification period makes it possible to investigate the impact of fetal exposure to extra vitamin D from food fortification on the risk of developing diseases later on. This study is possible due not only to the well-defined adjacent time window but also to the complete registration of every citizen via a civil registration number. This number can be linked, on an individual level, to Danish birth, patient and medical registries; social and ethnic registries; and clinical and other large databases
2. Case-cohort study: vitamin D measurements from dried blood spots and the risk of diseases later on
Interventions
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D-tect
1. This study is based on a unique Danish social experiment that took place during a well-defined period between 1937 and December 1985, when it was mandatory to fortify all margarine with vitamin D (1.25 μg/100 g). This well-defined vitamin D fortification period makes it possible to investigate the impact of fetal exposure to extra vitamin D from food fortification on the risk of developing diseases later on. This study is possible due not only to the well-defined adjacent time window but also to the complete registration of every citizen via a civil registration number. This number can be linked, on an individual level, to Danish birth, patient and medical registries; social and ethnic registries; and clinical and other large databases
2. Case-cohort study: vitamin D measurements from dried blood spots and the risk of diseases later on
Eligibility Criteria
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Inclusion Criteria
2. Sufficient amount of blood from the DBS
Exclusion Criteria
1. Born outside the fortification period
2. Insufficient amount of blood from the DBS or DBS not found
ALL
No
Sponsors
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The Danish Council for Strategic Research
OTHER
Bispebjerg Hospital
OTHER
Responsible Party
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Berit Lilienthal Heitmann
Professor
Locations
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Parker Institute
Frederiksberg, , Denmark
Countries
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References
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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.
Related Links
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Study website
Other Identifiers
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0603-00453B
Identifier Type: -
Identifier Source: org_study_id