Vitamin D Intervention in Infants (VIDI)

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Vitamin D Status

Treatments: Dietary Supplement: Vitamin D at 30 ug/day; Dietary Supplement: Vitamin D at 10 ug/day

Study type: Interventional

Funder types: Other

Identifiers

NCT01723852

VIDI-2012-01

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: Under 5 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,000 participants in 2 patient groups

Vitamin D supplement

Active Comparator group

Description:

Vitamin D supplement according to national guidelines (10 ug/day) from 2 weeks to 2 years of age

Treatment:

Dietary Supplement: Vitamin D at 10 ug/day

Vitamin D supplement at 30 ug/day

Active Comparator group

Description:

Vitamin D supplement at 30 ug/day from 2 weeks to 2 years of age

Treatment:

Dietary Supplement: Vitamin D at 30 ug/day