This trial is active, not recruiting.

Condition vitamin d status
Treatments vitamin d at 30 ug/day, vitamin d at 10 ug/day
Sponsor Helsinki University Central Hospital
Collaborator The Finnish Governmental Special Subsidy for Health Sciences Research
Start date January 2013
End date July 2016
Trial size 1000 participants
Trial identifier NCT01723852, VIDI-2012-01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
(Active Comparator)
Vitamin D supplement according to national guidelines (10 ug/day) from 2 weeks to 2 years of age
vitamin d at 10 ug/day
(Active Comparator)
Vitamin D supplement at 30 ug/day from 2 weeks to 2 years of age
vitamin d at 30 ug/day

Primary Outcomes

time frame: 2 years of age
Neurologic and cognitive development
time frame: At 2 years of age
Frequency of allergic symptoms and infection
time frame: At 2 years of age
Development of immunoregulation
time frame: At 2 years of age
Bone mineral density
time frame: 2 years of age

Eligibility Criteria

Male or female participants up to 5 days old.

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

Additional Information

Official title Vitamin D Intervention in Infants
Principal investigator Sture Andersson, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Helsinki University Central Hospital.