Vitamin D Status
Conditions
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
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Growth | 2 years of age | Measurement of growth at 2 years of age |
| Neurologic and cognitive development | At 2 years of age | By 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 infection | At 2 years of age | Assessment of the frequency of allergic symptoms and infections by means of questionnaires, hospital discharge records and prescription data. |
| Development of immunoregulation | At 2 years of age | Assessment of the tolerogenic properties of T-cells and dendritic cell function from blood sample in a subgroup of 100 study subjects. |
| Bone mineral density | 2 years of age | Bone mineral density is measured by dual energy x-ray absorptiometry and peripheral quantitative computerized tomography |
Countries
Finland