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Completed

NCT Number: NCT03330301

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

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.

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Key information

Conditions

Vitamin D Deficiency Arthritis Asthma Avitaminosis Birth Disorder Birth Weight Body Weight Bone Fracture Bronchial Diseases Cancer Congenital Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Fractures, Bone Glucose Metabolism Disorders Hypersensitivity Hypersensitivity, Immediate Hypertension, Pregnancy-Induced Immune System Diseases Joint Diseases Lung Diseases Lung Diseases, Obstructive Malnutrition Mental Disorder Mental Disorders Metabolic Diseases Musculoskeletal Diseases Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms Stomatognathic Diseases Tooth Diseases Urogenital Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Parker Institute

Frederiksberg, 2000, Denmark

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Born in Denmark around the fortification period
  • Sufficient amount of blood from the DBS

Exclusion criteria

1.Born outside Denmark

  • Born outside the fortification period
  • Insufficient amount of blood from the DBS or DBS not found

Treatment and study plan

D-tect

Other
  • 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

Primary outcomes

  1. Obesity

    Time frame: 2012-2025

    Register based

  2. Type 1 diabetes

    Time frame: 2012-2016

    Register based

  3. Pre-eclampsia

    Time frame: 2012-2025

    Register based

  4. Bone facture

    Time frame: 2012-2025

    Register based

Secondary outcomes

  1. Type 2 diabetes

    Time frame: 2014-2025

    Register based

  2. Gestational diabetes

    Time frame: 2014-2025

    Register based

  3. Asthma

    Time frame: 2015-2025

    Register based

  4. Arthritis

    Time frame: 2018-2025

    Register based

  5. Birth weight

    Time frame: 2014-2019

    Register based

  6. Mental diseases

    Time frame: 2012-2025

    Register based

Other outcomes

  1. Cancers

    Time frame: 2018-2025

    Register based

  2. Mental disorders

    Time frame: 2018-2025

    Register based

  3. Dental caries

    Time frame: 2018-2025

    Register based

  4. Congenital disorders

    Time frame: 2018-2025

    Register based

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • The Danish Council for Strategic Research

Registry information

Acronym: D-tect

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2017
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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