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NCT04302987: VIDI2

Vitamin D Intervention in Infants - 6 Years Follow-up (VIDI2)

Completed Last updated 3 November 2022
What this trial tests

trial in Bone Strength in 415 participants. Completed in 27 May 2022.

Timeline
1 November 2019
Primary endpoint
15 December 2021
27 May 2022

Quick facts

Lead sponsorUniversity of Helsinki
StatusCompleted
Study typeOBSERVATIONAL
Enrollment415
Start date1 November 2019
Primary completion15 December 2021
Estimated completion27 May 2022
Sites1 location across Finland

Conditions studied

Sponsor

University of Helsinki

Who can join

Adults 6 to 7, any sex, with Bone Strength or Growth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effect of Vitamin D3 Supplementation in the First 2 Years of Life on Psychiatric Symptoms at Ages 6 to 8 Years: A Randomized Clinical Trial.
    Sandboge S, Räikkönen K, Lahti-Pulkkinen M, Hauta-Alus H, et al · · 2023 · cited 8× · PMID 37204794 · DOI 10.1001/jamanetworkopen.2023.14319
  2. Low-grade inflammation from prenatal period to age 6-8 years in a Vitamin D trial.
    Hauta-Alus HH, Rosendahl J, Holmlund-Suila EM, Valkama SM, et al · · 2024 · cited 1× · PMID 38225452 · DOI 10.1038/s41390-024-03019-4
  3. Early life vitamin D and neurocognitive abilities at age 6-8 years: a randomized clinical trial and observational analysis.
    Seppälä V, Sandboge S, Holmlund-Suila E, Hauta-Alus H, et al · · 2026 · PMID 41071326 · DOI 10.1007/s00787-025-02891-7

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Other recruiting trials for Bone Strength

Currently open trials in the same condition.

Other University of Helsinki trials

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing