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

Completed

• Conditions: Arthritis; Obesity; Diabetes Mellitus; Pre-Eclampsia; Congenital Disorders; Asthma; Birth Weight; Birth Disorder; Cancer; Vitamin D Deficiency

• Registration Number: NCT03330301
• Lead Sponsor: Bispebjerg Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-01
• Primary Completion: 2016-09-30
• Study Completion: 2016-09-30
• Study First Submitted: 2017-10-31
• Study First Submitted QC: 2017-10-31
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222776

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pre-eclampsia	2012-2025	Register based
Bone facture	2012-2025	Register based
Obesity	2012-2025	Register based
Type 1 diabetes	2012-2016	Register based

Secondary Outcome Measures

Name	Time	Method
Asthma	2015-2025	Register based
Birth weight	2014-2019	Register based
Type 2 diabetes	2014-2025	Register based
Arthritis	2018-2025	Register based
Mental diseases	2012-2025	Register based
Gestational diabetes	2014-2025	Register based

Trial Locations

Locations (1)

Parker Institute; 🇩🇰 Frederiksberg, Denmark