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NCT Number: NCT04302987

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

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.

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Key information

Conditions

Bone Strength Allergic Diseases Body Composition Dental Health Growth Infection Infections

Age range

6 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital

Helsinki, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Primary outcomes

  1. Areal bone mineral quantity

    Time frame: 6.5 years

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

  2. Volumetric bone mineral density

    Time frame: 6.5 years

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

  3. Cross-sectional area of the bone

    Time frame: 6.5 years

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

  4. Bone mineral quantity

    Time frame: 6.5 years

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

  5. Bone mineral density

    Time frame: 6.5 years

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

  6. Serum intact parathyroid hormone

    Time frame: 6.5 years

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

  7. Plasma ionized calcium

    Time frame: 6.5 years

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

  8. Plasma alkaline phosphatase

    Time frame: 6.5 years

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

  9. Serum C-telopeptide of type I collagen

    Time frame: 6.5 years

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

  10. Plasma fibroblast growth factor 23

    Time frame: 6.5 years

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

  11. Morbidity due to infectious diseases

    Time frame: 6.5 years

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

  12. Morbidity due to allergic diseases

    Time frame: 6.5 years

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

  13. Weight

    Time frame: 6.5 years

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

  14. Height

    Time frame: 6.5 years

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

  15. Fat mass

    Time frame: 6.5 years

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

  16. Fat-free mass

    Time frame: 6.5 years

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

Secondary outcomes

  1. High sensitivity C-reactive protein

    Time frame: 6.5 years

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

  2. Plasma matrix metalloproteinase 8

    Time frame: 6.5 years

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

  3. Gene variants

    Time frame: 6.5 years

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

  4. Epigenetic changes

    Time frame: 6.5 years

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

  5. Cognitive abilities

    Time frame: 6.5 years

    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.

  6. Executive functioning

    Time frame: 6.5 years

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

  7. Psychiatric disorders and symptoms

    Time frame: 6.5 years

    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.

  8. Attention deficient and hyperactivity symptoms

    Time frame: 6.5 years

    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.

  9. Autism spectrum disorders and symptoms

    Time frame: 6.5 years

    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.

  10. Sleep

    Time frame: 6.5 years

    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.

  11. Temperament

    Time frame: 6.5 years

    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.

  12. Prevalence of molar-incisor hypomineralization

    Time frame: 6.5 years

    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

  13. Prevalence of caries

    Time frame: 6.5 years

    Clinical evaluation by dentist as decayed or filled tooth surfaces.

  14. Salivary matrix metalloproteinase 8 level

    Time frame: 6.5 years

    Salivary matrix metalloproteinase 8 is analysed with salivary sample test.

  15. SARS-CoV-2 virus antibodies

    Time frame: 6,.5 years

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

  16. SARS-CoV-2 virus

    Time frame: 6.5 years

    SARS-CoV-2 virus PCR is analyzed from saliva

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Registry information

Official study title

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

Acronym: VIDI2

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 10, 2020
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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