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

Not Applicable

Completed

• Conditions: Other Preterm Infants; Asthma; Pneumonia; Bronchiolitis; Vitamin D Deficiency
• Interventions: Dietary Supplement: Vitamin D

• Registration Number: NCT02404623
• Lead Sponsor: Soroka University Medical Center

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.

Study Timeline

• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-31
• Study Start: 2015-04
• Status Verified: 2018-02
• Primary Completion: 2018-02-12
• Study Completion: 2018-02-12
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Vitamin D	800 IU of Vitamin D once daily
Control Group	Vitamin D	400 IU of Vitamin D once daily, the standard of care

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
respiratory morbidity prevalence	first year	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).

Trial Locations

Locations (1)

Soroka University Medical Center; 🇮🇱 Beer- Sheva, P.O.Box 151, Israel