Vitamin D Intervention in Infants - 6 Years Follow-up (VIDI2)
- Conditions
- Body CompositionInfectionDental HealthBone StrengthAllergic DiseasesGrowth
- Registration Number
- NCT04302987
- Lead Sponsor
- University of Helsinki
- Brief 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. 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 415
All who participated in the original VIDI study until last study visit at the age of 2 years.
Exclusion criteria:
None
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Volumetric bone mineral density 6.5 years Bone mineral density in milligrams per cubic centimeter is measured by pQCT.
Areal bone mineral quantity 6.5 years Bone mineral quantity in milligrams per millimeter is measured by peripheral quantitative computed tomography (pQCT).
Cross-sectional area of the bone 6.5 years Cross-sectional area of the bone in square millimeters is measured by pQCT.
Bone mineral quantity 6.5 years Bone mineral quantity in grams is measured by dual-energy X-ray absorptiometry (DXA).
Serum C-telopeptide of type I collagen 6.5 years Serum C-telopeptide of type I collagen is measured with competitive polyclonal antibody assay.
Plasma fibroblast growth factor 23 6.5 years Plasma intact and C-terminal fibroblast growth factor 23 is determined with enzyme-linked immunosorbent assay.
Morbidity due to infectious diseases 6.5 years Morbidity due to infectious diseases in frequencies and type are to be collected via questionnaires filled in by parents.
Bone mineral density 6.5 years Bone mineral density in grams per centimeter squared is measured by DXA.
Serum intact parathyroid hormone 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.
Plasma alkaline phosphatase 6.5 years Plasma alkaline phosphatase concentration is measured from blood samples with photometric methods.
Height 6.5 years .Height in centimeters is measured with a Seca 285 digital measuring station
Morbidity due to allergic diseases 6.5 years Morbidity due to allergic diseases and symptoms are to be collected via questionnaires filled in by parents.
Fat mass 6.5 years Fat mass in kilograms based on ohms is measured by InBody bioelectrical impedance analysis.
Fat-free mass 6.5 years Fat-free mass in kilograms based on ohms is measured with InBody.
Plasma ionized calcium 6.5 years Plasma ionized calcium concentration is measured from blood samples with the blood gas analyzer ABL 90 FLEX or ABL 835 FLEX.
Weight 6.5 years Weight in kilograms is measured with a Seca 285 digital measuring station.
- Secondary Outcome Measures
Name Time Method Epigenetic changes 6.5 years Epigenetic changes associated with vitamin D metabolism and primary outcomes are performed using methylation assays.
High sensitivity C-reactive protein 6.5 years High sensitivity C-reactive protein is measured with enzyme immunoassay.
Cognitive abilities 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.
Autism spectrum disorders and symptoms 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.
Temperament 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.
Prevalence of caries 6.5 years Clinical evaluation by dentist as decayed or filled tooth surfaces.
Gene variants 6.5 years Gene variants associated with vitamin D metabolism and primary outcomes are performed using Sanger-sequencing, Taqman and genome-wide SNP-arrays.
Salivary matrix metalloproteinase 8 level 6.5 years Salivary matrix metalloproteinase 8 is analysed with salivary sample test.
Psychiatric disorders and symptoms 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.
Executive functioning 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.
Prevalence of molar-incisor hypomineralization 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
Plasma matrix metalloproteinase 8 6.5 years Plasma matrix metalloproteinase 8 is analysed with time-resolved immunofluorometric assay.
Attention deficient and hyperactivity symptoms 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.
Sleep 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.
SARS-CoV-2 virus antibodies 6,.5 years SARS-CoV-2 virus antibodies are measured from blood samples
SARS-CoV-2 virus 6.5 years SARS-CoV-2 virus PCR is analyzed from saliva
Trial Locations
- Locations (1)
Children's Hospital
🇫🇮Helsinki, Finland