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

Infection Clinical Trial

— VIDI2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302987
• Other study ID #: Helsinki University
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: May 27, 2022

Study information

• Verified date: October 2022
• Source: University of Helsinki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: May 27, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 7 Years

Eligibility

Inclusion Criteria:

All who participated in the original VIDI study until last study visit at the age of 2 years. Exclusion criteria: None

Related Conditions & MeSH terms

• Allergic Diseases
• Body Composition
• Bone Strength
• Dental Health
• Growth
• Infection

Locations

Country	Name	City	State
Finland	Children's Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

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