Clinical trial NCT04302987: Vitamin D Intervention in Infants - 6 Years Follow-up (VIDI2)
Official title: VITAMIN D INTERVENTION IN INFANTS: Effects of Early Vitamin D Exposure on Childhood Health at 6 Years - a Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Strength
Growth
Body Composition
Infection
Allergic Diseases
Dental Health
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 415
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion criteria:

None

Primary outcomes:
measure: Areal bone mineral quantity
timeFrame: 6.5 years
measure: Volumetric bone mineral density
timeFrame: 6.5 years
measure: Cross-sectional area of the bone
timeFrame: 6.5 years
measure: Bone mineral quantity
timeFrame: 6.5 years
measure: Bone mineral density
timeFrame: 6.5 years
measure: Serum intact parathyroid hormone
timeFrame: 6.5 years
measure: Plasma ionized calcium
timeFrame: 6.5 years
measure: Plasma alkaline phosphatase
timeFrame: 6.5 years
measure: Serum C-telopeptide of type I collagen
timeFrame: 6.5 years
measure: Plasma fibroblast growth factor 23
timeFrame: 6.5 years
measure: Morbidity due to infectious diseases
timeFrame: 6.5 years
measure: Morbidity due to allergic diseases
timeFrame: 6.5 years
measure: Weight
timeFrame: 6.5 years
measure: Height
timeFrame: 6.5 years
measure: Fat mass
timeFrame: 6.5 years
measure: Fat-free mass
timeFrame: 6.5 years
Secondary outcomes:
measure: High sensitivity C-reactive protein
timeFrame: 6.5 years
measure: Plasma matrix metalloproteinase 8
timeFrame: 6.5 years
measure: Gene variants
timeFrame: 6.5 years
measure: Epigenetic changes
timeFrame: 6.5 years
measure: Cognitive abilities
timeFrame: 6.5 years
measure: Executive functioning
timeFrame: 6.5 years
measure: Psychiatric disorders and symptoms
timeFrame: 6.5 years
measure: Attention deficient and hyperactivity symptoms
timeFrame: 6.5 years
measure: Autism spectrum disorders and symptoms
timeFrame: 6.5 years
measure: Sleep
timeFrame: 6.5 years
measure: Temperament
timeFrame: 6.5 years
measure: Prevalence of molar-incisor hypomineralization
timeFrame: 6.5 years
measure: Prevalence of caries
timeFrame: 6.5 years
measure: Salivary matrix metalloproteinase 8 level
timeFrame: 6.5 years
measure: SARS-CoV-2 virus antibodies
timeFrame: 6,.5 years
measure: SARS-CoV-2 virus
timeFrame: 6.5 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Children's Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Sture Andersson, MD
role: PRINCIPAL_INVESTIGATOR
References: