NCT02404623

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: All
• Age: 33 Weeks – 37 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Other Preterm Infants
• Vitamin D Deficiency
• Bronchiolitis
• Asthma
• Pneumonia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin 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

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-02-12
• Completion: 2018-02-12
• First posted: 2015-03-31
• Last updated: 2018-02-14

Locations

1 site across 1 country: Israel