CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 415 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT04302987
NCT04302987N/ACompleted

VITAMIN D INTERVENTION IN INFANTS: Effects of Early Vitamin D Exposure on Childhood Health at 6 Years - a Follow-up Study

University of Helsinki·observational·Posted Mar 10, 2020·Updated Nov 3, 2022

In Brief

An observational study for Bone Strength and 5 related conditions. Completed, enrolled 415 participants across 1 site.

Detailed Summary

Exposure to vitamin D intervention in early life may have permanent effects on physiology and metabolism. Bone growth and mineralization, development of immunity, body composition and brain structure and functioning may be affected. The importance of a long-term surveillance includes follow-up of both beneficial but also harmful effects of vitamin D. Vitamin D intervention in infants (VIDI) study was conducted in 2013-2016. VIDI study was a large randomized trial that aimed to evaluate effects of two vitamin D supplemental doses of daily 10 ug and 30 ug from the age 2 weeks until 2 years on bone strength, infections, immunity, allergy, atopy and asthma, neurologic and cognitive development, and genetic regulation of mineral homeostasis. Current study is a 6 Years Follow-up (VIDI2) study of the original VIDI trial. Our focuses of interest in the follow-up are: bone strength, growth pattern, body composition, and morbidity due to infections and allergic diseases, and the development of immunity. Further, in addition to more classical associates of vitamin D, our aim is to continue to follow-up children's neurocognitive development and mental health. We will also focus on the effect of vitamin D supplementation on occurrence of molar-incisor hypomineralization, dental caries, and oral immunity.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFinland
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 10, 2020
Enrollment StartNov 1, 2019
Primary CompletionDec 15, 2021
Study CompletionMay 27, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.3 years ago