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Vitamin D Intervention in Infants

Vitamin D Intervention in Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01723852
Acronym
VIDI
Enrollment
1000
Registered
2012-11-08
Start date
2013-01-31
Completion date
2017-11-20
Last updated
2017-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Status

Keywords

Vitamin D, Infectious diseases, cognitive development, Bone mineral density, Immunoregulation, Allergy, Growth

Brief summary

The study is a randomized, controlled, double blinded study evaluating the effect of recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2 years of age, on growth, bone development, neurologic and cognitive development, frequence of infectious diseases, allergic symptoms, and development of immunoregulation assessed at 2 years of age.

Interventions

DIETARY_SUPPLEMENTVitamin D at 30 ug/day
DIETARY_SUPPLEMENTVitamin D at 10 ug/day

Sponsors

The Finnish Governmental Special Subsidy for Health Sciences Research
CollaboratorUNKNOWN
Päivikki and Sakari Sohlberg Foundation, Finland
CollaboratorOTHER
The Finnish Medical Association
CollaboratorOTHER
Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Days
Healthy volunteers
Yes

Inclusion criteria

* Infants born at term (37-42 wks, weight appropriate for gestational age) are included in the study

Exclusion criteria

* Non Caucasian mother * Any continuous regular medication of mother * Treatment at neonatal intensive care unit * Antibiotic treatment of the infant * Congenital malformations of the newborn * Treatment with ventilation support (continuous nasal positive airway pressure) for over 24 hours * Glucose infusion of the newborn * Neurological symptoms of the newborn * Phototherapy for jaundice of the newborn * Need for nasogastric feeding of the newborn

Design outcomes

Primary

MeasureTime frameDescription
Growth2 years of ageMeasurement of growth at 2 years of age
Neurologic and cognitive developmentAt 2 years of ageBy means of questionnaires and, on a randomly selected group of study subjects, cognitive function testing to assess neurologic and cognitive development
Frequency of allergic symptoms and infectionAt 2 years of ageAssessment of the frequency of allergic symptoms and infections by means of questionnaires, hospital discharge records and prescription data.
Development of immunoregulationAt 2 years of ageAssessment of the tolerogenic properties of T-cells and dendritic cell function from blood sample in a subgroup of 100 study subjects.
Bone mineral density2 years of ageBone mineral density is measured by dual energy x-ray absorptiometry and peripheral quantitative computerized tomography

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026