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 Type
OBSERVATIONAL
Enrollment
415
Children's Hospital
Helsinki, Finland
Areal bone mineral quantity
Bone mineral quantity in milligrams per millimeter is measured by peripheral quantitative computed tomography (pQCT).
Time frame: 6.5 years
Volumetric bone mineral density
Bone mineral density in milligrams per cubic centimeter is measured by pQCT.
Time frame: 6.5 years
Cross-sectional area of the bone
Cross-sectional area of the bone in square millimeters is measured by pQCT.
Time frame: 6.5 years
Bone mineral quantity
Bone mineral quantity in grams is measured by dual-energy X-ray absorptiometry (DXA).
Time frame: 6.5 years
Bone mineral density
Bone mineral density in grams per centimeter squared is measured by DXA.
Time frame: 6.5 years
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.
Time frame: 6.5 years
Plasma ionized calcium
Plasma ionized calcium concentration is measured from blood samples with the blood gas analyzer ABL 90 FLEX or ABL 835 FLEX.
Time frame: 6.5 years
Plasma alkaline phosphatase
Plasma alkaline phosphatase concentration is measured from blood samples with photometric methods.
Time frame: 6.5 years
Serum C-telopeptide of type I collagen
Serum C-telopeptide of type I collagen is measured with competitive polyclonal antibody assay.
Time frame: 6.5 years
Plasma fibroblast growth factor 23
Plasma intact and C-terminal fibroblast growth factor 23 is determined with enzyme-linked immunosorbent assay.
Time frame: 6.5 years
Morbidity due to infectious diseases
Morbidity due to infectious diseases in frequencies and type are to be collected via questionnaires filled in by parents.
Time frame: 6.5 years
Morbidity due to allergic diseases
Morbidity due to allergic diseases and symptoms are to be collected via questionnaires filled in by parents.
Time frame: 6.5 years
Weight
Weight in kilograms is measured with a Seca 285 digital measuring station.
Time frame: 6.5 years
Height
.Height in centimeters is measured with a Seca 285 digital measuring station
Time frame: 6.5 years
Fat mass
Fat mass in kilograms based on ohms is measured by InBody bioelectrical impedance analysis.
Time frame: 6.5 years
Fat-free mass
Fat-free mass in kilograms based on ohms is measured with InBody.
Time frame: 6.5 years
High sensitivity C-reactive protein
High sensitivity C-reactive protein is measured with enzyme immunoassay.
Time frame: 6.5 years
Plasma matrix metalloproteinase 8
Plasma matrix metalloproteinase 8 is analysed with time-resolved immunofluorometric assay.
Time frame: 6.5 years
Gene variants
Gene variants associated with vitamin D metabolism and primary outcomes are performed using Sanger-sequencing, Taqman and genome-wide SNP-arrays.
Time frame: 6.5 years
Epigenetic changes
Epigenetic changes associated with vitamin D metabolism and primary outcomes are performed using methylation assays.
Time frame: 6.5 years
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.
Time frame: 6.5 years
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.
Time frame: 6.5 years
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.
Time frame: 6.5 years
Attention deficient and hyperactivity symptoms
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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.
Time frame: 6.5 years
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.
Time frame: 6.5 years
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.
Time frame: 6.5 years
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.
Time frame: 6.5 years
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
Time frame: 6.5 years
Prevalence of caries
Clinical evaluation by dentist as decayed or filled tooth surfaces.
Time frame: 6.5 years
Salivary matrix metalloproteinase 8 level
Salivary matrix metalloproteinase 8 is analysed with salivary sample test.
Time frame: 6.5 years
SARS-CoV-2 virus antibodies
SARS-CoV-2 virus antibodies are measured from blood samples
Time frame: 6,.5 years
SARS-CoV-2 virus
SARS-CoV-2 virus PCR is analyzed from saliva
Time frame: 6.5 years