The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity During the First Year of Life

Conditions
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Asthma, Other Preterm Infants, Vitamin D Deficiency, Bronchiolitis, Pneumonia

Intervention / Treatment
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* Dietary Supplement: Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infant born at 32+6 to 36+6 weeks of gestational age Born at Soroka University Medical Center Signed informed consent Participants in the trial will be insured by Clalit HMO Exclusion Criteria: Chromosomal abnormality Neurological or muscular congenital anomalies Congenital cardiac defect Congenital respiratory anomalies Congenital GIT/ liver/ renal anomalies that effect the absorption and/or metabolism of Vitamin D and/or other substances. Admission after birth to NICU persists more than 5 days

Ages Eligible for Study
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Minimum Age: 33 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>800 IU of Vitamin D once daily | Dietary Supplement: Vitamin D<br>* 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<br>|
| Other: Control Group<br>400 IU of Vitamin D once daily, the standard of care | Dietary Supplement: Vitamin D<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory morbidity prevalence | Reports given by the parents via questionnaire at 3, 6, 9 and 12 months. | first year | 
| respiratory morbidity prevalence | Information collected from medical records containing the data of diagnosis or admission to pediatrics departments due to: bronchiolitis, wheezing, upper or lower respiratory tract infections, asthma and pneumonia | first year | 
| respiratory morbidity prevalence | Information collected from medical records containing the data of medication consumption such as bronchodilators, inhaled corticosteroid, systemic corticosteroids (along with respiratory disease) and antibiotics (along with respiratory infection). | first year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Respiratory Morbidity, prematurity