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Bone StrengthVIDI2NCT04302987

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

An observational study of Bone Strength and Growth, run by University of Helsinki at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 7 yearsHealthy volunteers can take part
Conditions the study is for
Bone Strength, Growth, Body Composition
How many people
415 participants
Where
1 siteFinland
Study dates
1 Nov 2019to 27 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 7 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: In the original VIDI study the eligible infants were born at term (37 weeks and 0 days' to 42 weeks and 0 days' gestation), with a birth weight within 2 SDs of the mean for gestational age. Infants excluded were those requiring intravenous glucose, antibiotics, nasal continuous positive airway pressure treatment for more than 1 day, phototherapy for more than 3 days, or nasogastric tube feeding for more than 1 day and infants with seizures.

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Children's Hospital

    Helsinki

Other trials in Finland

About this study

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

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.

Medical subject headings
Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Areal bone mineral quantity

    Bone mineral quantity in milligrams per millimeter is measured by peripheral quantitative computed tomography (pQCT).

    Measured: 6.5 years

  2. Volumetric bone mineral density

    Bone mineral density in milligrams per cubic centimeter is measured by pQCT.

    Measured: 6.5 years

  3. Cross-sectional area of the bone

    Cross-sectional area of the bone in square millimeters is measured by pQCT.

    Measured: 6.5 years

  4. Bone mineral quantity

    Bone mineral quantity in grams is measured by dual-energy X-ray absorptiometry (DXA).

    Measured: 6.5 years

  5. Bone mineral density

    Bone mineral density in grams per centimeter squared is measured by DXA.

    Measured: 6.5 years

  6. Serum intact parathyroid hormone

    Serum intact parathyroid hormone concentration is measured from blood samples with the blood gas analyzer ABL 90 FLEX or ABL 835 FLEX.

    Measured: 6.5 years

  7. Plasma ionized calcium

    Plasma ionized calcium concentration is measured from blood samples with the blood gas analyzer ABL 90 FLEX or ABL 835 FLEX.

    Measured: 6.5 years

  8. Plasma alkaline phosphatase

    Plasma alkaline phosphatase concentration is measured from blood samples with photometric methods.

    Measured: 6.5 years

  9. Serum C-telopeptide of type I collagen

    Serum C-telopeptide of type I collagen is measured with competitive polyclonal antibody assay.

    Measured: 6.5 years

  10. Plasma fibroblast growth factor 23

    Plasma intact and C-terminal fibroblast growth factor 23 is determined with enzyme-linked immunosorbent assay.

    Measured: 6.5 years

  11. Morbidity due to infectious diseases

    Morbidity due to infectious diseases in frequencies and type are to be collected via questionnaires filled in by parents.

    Measured: 6.5 years

  12. Morbidity due to allergic diseases

    Morbidity due to allergic diseases and symptoms are to be collected via questionnaires filled in by parents.

    Measured: 6.5 years

  13. Weight

    Weight in kilograms is measured with a Seca 285 digital measuring station.

    Measured: 6.5 years

  14. Height

    .Height in centimeters is measured with a Seca 285 digital measuring station

    Measured: 6.5 years

  15. Fat mass

    Fat mass in kilograms based on ohms is measured by InBody bioelectrical impedance analysis.

    Measured: 6.5 years

  16. Fat-free mass

    Fat-free mass in kilograms based on ohms is measured with InBody.

    Measured: 6.5 years

Secondary outcomes (16)

  1. High sensitivity C-reactive protein

    High sensitivity C-reactive protein is measured with enzyme immunoassay.

    Measured: 6.5 years

  2. Plasma matrix metalloproteinase 8

    Plasma matrix metalloproteinase 8 is analysed with time-resolved immunofluorometric assay.

    Measured: 6.5 years

  3. Gene variants

    Gene variants associated with vitamin D metabolism and primary outcomes are performed using Sanger-sequencing, Taqman and genome-wide SNP-arrays.

    Measured: 6.5 years

  4. Epigenetic changes

    Epigenetic changes associated with vitamin D metabolism and primary outcomes are performed using methylation assays.

    Measured: 6.5 years

  5. Cognitive abilities

    Cognitive abilities are measured with Wechsler Intelligence Scale for Children-IV. Scales are scored according to the manual and standardized total scores vary between 10 and 159. Higher scores present better performance.

    Measured: 6.5 years

  6. Executive functioning

    Executive functions are measured with performance based test called NEPSY-II. Scales are scored according to the manual. Higher scores represent better performance.

    Measured: 6.5 years

  7. Psychiatric disorders and symptoms

    Psychiatric disorders and symptoms are measured with parent-rated questionnaire: the Child behavioral checklist. Scales are scored according to the manual. Maximum and minimum values very between subscales scales. Higher scores represent worse outcomes, i.e. more psychiatric symptoms.

    Measured: 6.5 years

  8. Attention deficient and hyperactivity symptoms

    Attention deficient and hyperactivity symptoms are measured with parent rated 'ADHD Rating Scale IV'-questionnaire. Scales are scored according to the published guidelines and higher scores reflect more problems.

    Measured: 6.5 years

  9. Autism spectrum disorders and symptoms

    Parent-rated Autism Spectrum Screening Questionnaire is used to measure Autism spectrum disorders and symptoms. Scales are scored according to the published guidelines and higher scores reflect more problems.

    Measured: 6.5 years

  10. Sleep

    Sleep is measured using a parent rated Sleep Disturbance Scale for Children. Questionnaire is scored according to publishers guidelines and the minimum and maximum scores vary. Higher scores in disturbance scales present worse outcome whereas a longer time at sleep represents a better outcome.

    Measured: 6.5 years

  11. Temperament

    Temperament is measured using parent rated questionnaire 'The Children's Behavior Questionnaire'. Questionnaire is scored according to manual and the minimum and maximum scores vary by temperament dimension. Higher scores do not as such mean better or worse outcome.

    Measured: 6.5 years

  12. Prevalence of molar-incisor hypomineralization

    Clinical evaluation by dentist of tooth enamel opacities, posteruptive enamel breakdown, atypical restorations, and/or extractions of molars according to the European Academy of Paediatric Dentistry criteria

    Measured: 6.5 years

  13. Prevalence of caries

    Clinical evaluation by dentist as decayed or filled tooth surfaces.

    Measured: 6.5 years

  14. Salivary matrix metalloproteinase 8 level

    Salivary matrix metalloproteinase 8 is analysed with salivary sample test.

    Measured: 6.5 years

  15. SARS-CoV-2 virus antibodies

    SARS-CoV-2 virus antibodies are measured from blood samples

    Measured: 6,.5 years

  16. SARS-CoV-2 virus

    SARS-CoV-2 virus PCR is analyzed from saliva

    Measured: 6.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2020
  2. Study start1 Nov 2019
  3. Primary completion15 Dec 2021
  4. Study completion27 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04302987
Sponsor's protocol ID
Helsinki University
Acronym
VIDI2
Status last verified
Oct 2022
First submitted
24 Feb 2020
Last updated
3 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sandboge S, Seppala V, Lintula S, Holmlund-Suila E, Hauta-Alus H, Kajantie E, Makitie O, Andersson S, Raikkonen K, Heinonen K. Vitamin D supplementation in the first 2 years and autism spectrum traits at 6-8 years - a randomized clinical trial. J Child Psychol Psychiatry. 2026 Jul;67(7):1004-1014. doi: 10.1111/jcpp.70110. Epub 2026 Jan 5.

    PubMed 41486975

  • 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. 2026 Feb;35(2):587-597. doi: 10.1007/s00787-025-02891-7. Epub 2025 Oct 10.

    PubMed 41071326

  • 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.

    PubMed 37204794

Questions about this trial

What is this clinical trial studying?

An observational study of Bone Strength and Growth, run by University of Helsinki at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Areal bone mineral quantity (time frame: 6.5 years). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04302987, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.

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