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

NCT ID: NCT04302987

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

415 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-05-27

Brief Summary

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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.

Detailed Description

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Conditions

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Bone Strength Growth Body Composition Infection Allergic Diseases Dental Health

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

All who participated in the original VIDI study until last study visit at the age of 2 years.

Exclusion Criteria

None
Minimum Eligible Age

6 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Sture Andersson

Professor Sture Andersson

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sture Andersson, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Children's Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

References

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Seppala V, Sandboge S, Holmlund-Suila E, Hauta-Alus H, Lintula S, Kajantie E, Makitie O, Andersson S, Raikkonen K, Heinonen K. Early life vitamin D and neurocognitive abilities at age 6-8 years: a randomized clinical trial and observational analysis. Eur Child Adolesc Psychiatry. 2025 Oct 10. doi: 10.1007/s00787-025-02891-7. Online ahead of print.

Reference Type DERIVED
PMID: 41071326 (View on PubMed)

Sandboge S, Raikkonen K, Lahti-Pulkkinen M, Hauta-Alus H, Holmlund-Suila E, Girchenko P, Kajantie E, Makitie O, Andersson S, Heinonen K. 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. JAMA Netw Open. 2023 May 1;6(5):e2314319. doi: 10.1001/jamanetworkopen.2023.14319.

Reference Type DERIVED
PMID: 37204794 (View on PubMed)

Other Identifiers

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Helsinki University

Identifier Type: -

Identifier Source: org_study_id

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