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CompletedNCT03330301D-tectUpdated Nov 6, 2017

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

An observational study in Vitamin D Deficiency, Obesity and Diabetes Mellitus, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2017-11-06.

Sponsored by Bispebjerg Hospital · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
222,776
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Vitamin D Deficiency with a site in Denmark — none open to participants now, none under way, none of them phase 3. Vitamin D Deficiency · Denmark.

Started
2012
with 1 other
Observational
2 of 17
none open now
Registered
15th of 17
by date
Lead sponsor
1 of 17
Bispebjerg Hospital

Among the 17 studies in Vitamin D Deficiency with a site in Denmark, this one is one of 2 that started in 2012, is one of 2 observational ones, and was the 15th registered.

By phase

17 studies; the count open now beside each. This study's row is marked.

No phase8 · 0 open
Phase 43 · 0 open
Observationalthis study2 · 0 open
Phase 22 · 0 open
Phase 11 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2001; this study’s year is marked. 2 started in 2012.

Size and results

Median enrollment 102 across the 15 interventional studies, 111,612 across the 2 observational. Of the 14 that completed or were terminated, 2 (14%) have results posted.

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Download CSVWith an account: the 17 studies in Vitamin D Deficiency with a site in Denmark as a file.
02

Study 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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

1.Born outside Denmark

  1. Born outside the fortification period
  2. Insufficient amount of blood from the DBS or DBS not found
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
222,776 participants (actual)
Target follow-up
33 Years
Patient registry
Yes

Groups and cohorts

  • 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

    Other: D-tect

  • 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

    Other: D-tect

Interventions

  • OtherD-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

06

What researchers measure

Primary outcomes

  1. Obesity

    Register based

    Time frame: 2012-2025

  2. Type 1 diabetes

    Register based

    Time frame: 2012-2016

  3. Pre-eclampsia

    Register based

    Time frame: 2012-2025

  4. Bone facture

    Register based

    Time frame: 2012-2025

Secondary outcomes

  1. Type 2 diabetes

    Register based

    Time frame: 2014-2025

  2. Gestational diabetes

    Register based

    Time frame: 2014-2025

  3. Asthma

    Register based

    Time frame: 2015-2025

  4. Arthritis

    Register based

    Time frame: 2018-2025

  5. Birth weight

    Register based

    Time frame: 2014-2019

  6. Mental diseases

    Register based

    Time frame: 2012-2025

Other outcomes

  1. Cancers

    Register based

    Time frame: 2018-2025

  2. Mental disorders

    Register based

    Time frame: 2018-2025

  3. Dental caries

    Register based

    Time frame: 2018-2025

  4. Congenital disorders

    Register based

    Time frame: 2018-2025

07

Study locations

1 site
  • Parker Institute
    Frederiksberg, 2000, Denmark
08

References and documents

Publications

  • 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. PubMed 30388966 ↗

Related links

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2012 to primary completion in Sep 2016, 53 months.

Of 61 non-industry observational studies under Vitamin D Deficiency, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 40. This study's 53 months is above that.

Counting every sponsor, half of 62 studies reached it within 19 months; a quarter within 9 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 31, 2017
First posted
Nov 6, 2017
StartActual
Apr 1, 2012
Primary completionActual
Sep 30, 2016
CompletionActual
Sep 30, 2016
Last update
Nov 6, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03330301
Collaborators
The Danish Council for Strategic Research
Responsible party
Berit Lilienthal Heitmann (Professor, Bispebjerg Hospital) — Principal investigator
First posted
Nov 6, 2017
Start date
Apr 1, 2012
Primary completion
Sep 30, 2016
Completion
Sep 30, 2016
Last update
Nov 6, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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