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

Obesity Clinical Trial

— D-tect  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330301
• Other study ID #: 0603-00453B
• Status: Completed
• Phase: N/A
• First received: October 31, 2017
• Last updated: November 2, 2017
• Start date: April 1, 2012
• Est. completion date: September 30, 2016

Study information

• Verified date: November 2017
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222776
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Asthma
• Birth Disorder
• Birth Weight
• Bone Fracture
• Cancer
• Congenital Disorders
• Diabetes Mellitus
• Disease
• Eclampsia
• Fractures, Bone
• Mental Disorder
• Mental Disorders
• Obesity
• Pre-Eclampsia
• Pregnancy Complications
• Psychotic Disorders
• Tooth Diseases
• Vitamin D Deficiency

Intervention

Other:
• D-tect
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

Locations

Country	Name	City	State
Denmark	Parker Institute	Frederiksberg

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	The Danish Council for Strategic Research

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cancers	Register based	2018-2025
Other	Mental disorders	Register based	2018-2025
Other	Dental caries	Register based	2018-2025
Other	Congenital disorders	Register based	2018-2025
Primary	Obesity	Register based	2012-2025
Primary	Type 1 diabetes	Register based	2012-2016
Primary	Pre-eclampsia	Register based	2012-2025
Primary	Bone facture	Register based	2012-2025
Secondary	Type 2 diabetes	Register based	2014-2025
Secondary	Gestational diabetes	Register based	2014-2025
Secondary	Asthma	Register based	2015-2025
Secondary	Arthritis	Register based	2018-2025
Secondary	Birth weight	Register based	2014-2019
Secondary	Mental diseases	Register based	2012-2025

External Links

•   Study website