D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life (D-tect)
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|ClinicalTrials.gov Identifier: NCT03330301|
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
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.
|Condition or disease||Intervention/treatment|
|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||Other: D-tect|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||222776 participants|
|Observational Model:||Ecologic or Community|
|Target Follow-Up Duration:||33 Years|
|Official Title:||D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life|
|Actual Study Start Date :||April 1, 2012|
|Actual Primary Completion Date :||September 30, 2016|
|Actual Study Completion Date :||September 30, 2016|
- 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
- Type 2 diabetes [ Time Frame: 2014-2025 ]Register based
- Gestational diabetes [ Time Frame: 2014-2025 ]Register based
- Asthma [ Time Frame: 2015-2025 ]Register based
- Arthritis [ Time Frame: 2018-2025 ]Register based
- Birth weight [ Time Frame: 2014-2019 ]Register based
- Mental diseases [ Time Frame: 2012-2025 ]Register based
- Cancers [ Time Frame: 2018-2025 ]Register based
- Mental disorders [ Time Frame: 2018-2025 ]Register based
- Dental caries [ Time Frame: 2018-2025 ]Register based
- Congenital disorders [ Time Frame: 2018-2025 ]Register based
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330301
|Frederiksberg, Denmark, 2000|