D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life
D-tect
1 other identifier
observational
222,776
1 country
1
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.
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2016
CompletedFirst Submitted
Initial submission to the registry
October 31, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedNovember 6, 2017
November 1, 2017
4.5 years
October 31, 2017
November 2, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Obesity
Register based
2012-2025
Type 1 diabetes
Register based
2012-2016
Pre-eclampsia
Register based
2012-2025
Bone facture
Register based
2012-2025
Secondary Outcomes (6)
Type 2 diabetes
2014-2025
Gestational diabetes
2014-2025
Asthma
2015-2025
Arthritis
2018-2025
Birth weight
2014-2019
- +1 more secondary outcomes
Other Outcomes (4)
Cancers
2018-2025
Mental disorders
2018-2025
Dental caries
2018-2025
- +1 more other outcomes
Study Arms (2)
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
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
Interventions
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
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)
You may qualify if:
- Born in Denmark around the fortification period
- Sufficient amount of blood from the DBS
You may not qualify if:
- Born outside Denmark
- Born outside the fortification period
- Insufficient amount of blood from the DBS or DBS not found
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bispebjerg Hospitallead
- The Danish Council for Strategic Researchcollaborator
Study Sites (1)
Parker Institute
Frederiksberg, 2000, Denmark
Related Publications (1)
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.
PMID: 30388966DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 33 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 31, 2017
First Posted
November 6, 2017
Study Start
April 1, 2012
Primary Completion
September 30, 2016
Study Completion
September 30, 2016
Last Updated
November 6, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share