Vitamin D DeficiencyD-tectNCT03330301
D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life
An observational study of Vitamin D Deficiency and Obesity, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vitamin D Deficiency, Obesity, Diabetes Mellitus
- What is being tested?
- D-tect
- How many people
- 222,776 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2012to 30 Sep 2016
- How long will I take part?
- 33 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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)
Who may be able to join
- Born in Denmark around the fortification period
- Sufficient amount of blood from the DBS
Who cannot join
- 1.Born outside Denmark
- Born outside the fortification period
- Insufficient amount of blood from the DBS or DBS not found
Trial locations and contacts
1 site in 1 country.
About this study
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):
Read more
- 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.
- 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.
- Conditions
- Vitamin D Deficiency, Obesity, Diabetes Mellitus, Pre-Eclampsia, Arthritis, Asthma
- Being tested
- D-tect
- Medical subject headings
- Vitamin D Deficiency, Obesity, Diabetes Mellitus, Pre-Eclampsia, Arthritis, Asthma, Fractures, Bone, Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-tectOther
- 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
- Case-cohort study: vitamin D measurements from dried blood spots and the risk of diseases later on
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: D-tect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity
Register based
Measured: 2012-2025
Type 1 diabetes
Register based
Measured: 2012-2016
Pre-eclampsia
Register based
Measured: 2012-2025
Bone facture
Register based
Measured: 2012-2025
Secondary outcomes (6)
Type 2 diabetes
Register based
Measured: 2014-2025
Gestational diabetes
Register based
Measured: 2014-2025
Asthma
Register based
Measured: 2015-2025
Arthritis
Register based
Measured: 2018-2025
Birth weight
Register based
Measured: 2014-2019
Mental diseases
Register based
Measured: 2012-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Apr 2012
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 222,776 participants (actual)
- Target duration
- 33 Years
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Council for Strategic Research
- Responsible party
- Principal investigator, Berit Lilienthal Heitmann, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330301
- Sponsor's protocol ID
- 0603-00453B
- Acronym
- D-tect
- Status last verified
- Nov 2017
- First submitted
- 31 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life
- ClinicalTrials.gov ID
- NCT03330301
- Acronym / sponsor ID
- D-tect / 0603-00453B
- Conditions
- Vitamin D Deficiency, Obesity, Diabetes Mellitus, Pre-Eclampsia, Arthritis, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222,776 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- The Danish Council for Strategic Research
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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.
- 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 33 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Other: D-tect1. 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 | – | Other: D-tect1. 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 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- Born in Denmark around the fortification period
- Sufficient amount of blood from the DBS
Key exclusion criteria (3 listed)
- 1.Born outside Denmark
- Born outside the fortification period
- Insufficient amount of blood from the DBS or DBS not found
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-tect1. 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 | Other | Exposed, Non-exposed |
Primary outcome
Obesity
Time frame: 2012-2025
Register based
Type 1 diabetes
Time frame: 2012-2016
Register based
Pre-eclampsia
Time frame: 2012-2025
Register based
Bone facture
Time frame: 2012-2025
Register based
6 secondary outcomes
Type 2 diabetes
Time frame: 2014-2025
Gestational diabetes
Time frame: 2014-2025
Asthma
Time frame: 2015-2025
Arthritis
Time frame: 2018-2025
Birth weight
Time frame: 2014-2019
Mental diseases
Time frame: 2012-2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 30388966Keller 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.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Obesity, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obesity (time frame: 2012-2025). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03330301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.