Asthma, Bronchiolitis, Other Preterm Infants, Pneumonia, Vitamin D Deficiency
Conditions
Keywords
Vitamin D, Respiratory Morbidity, prematurity
Brief summary
This trial objective is to assess whether doubling the daily intake of vitamin D improves serum vitamin D levels and serves as primary prevention of respiratory infections and asthma in premature infants. This is a prospective randomized (1:1) double-blinded trial. The study population will be randomized into two groups (1:1): * Intervention Group - 800 IU of Vitamin D once daily * Control Group - 400 IU of Vitamin D once daily Patients will be followed up for one year after randomization for serum Vitamin D levels and respiratory morbidity.
Detailed description
The rational of this trial is that a daily supplementation of a double dose of Vitamin D (800 IU instead of 400 IU) to late premature infants during the first year of life will result in elevated Vitamin D serum levels and in an improvement in respiratory morbidity. This randomized trial of vitamin D supplementation is planned to determine the optimal dose of daily vitamin D supplementation required to achieve sufficient vitamin D levels in preterm infants and to assess whether doubling the daily intake of vitamin D may serve as primary prevention of respiratory infections and asthma in premature infants.
Interventions
DIETARY_SUPPLEMENTVitamin D
also known as Cholecalciferol, is one of the two most important compounds within the group of Vitamin D. It can be ingested from the diet and from supplements. In this study it is pharmacologically acquired and referred to as Vitamin D
Sponsors
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
33 Weeks to 37 Weeks
Healthy volunteers
Yes
Inclusion criteria
1. Preterm infant born at 32+6 to 36+6 weeks of gestational age 2. Born at Soroka University Medical Center 3. Signed informed consent 4. Participants in the trial will be insured by Clalit HMO
Exclusion criteria
1. Chromosomal abnormality 2. Neurological or muscular congenital anomalies 3. Congenital cardiac defect 4. Congenital respiratory anomalies 5. Congenital GIT/ liver/ renal anomalies that effect the absorption and/or metabolism of Vitamin D and/or other substances. 6. Admission after birth to NICU persists more than 5 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improved serum vitamin D levels in the intervention group (receiving 800 IU daily) in comparison to the control group (receiving 400 IU daily) | 12 months of age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| respiratory morbidity prevalence | first year | Reports given by the parents via questionnaire at 3, 6, 9 and 12 months. |
Countries
Israel
Outcome results
None listed