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

Soroka University Medical Center

Status: Completed

Conditions: Asthma; Bronchiolitis; Vitamin D Deficiency; Pneumonia; Other Preterm Infants

Treatments: Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT02404623

SOR -0292-14-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 33 to 37 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Intervention Group

Experimental group

Description:

800 IU of Vitamin D once daily

Treatment:

Dietary Supplement: Vitamin D

Control Group

Other group

Description:

400 IU of Vitamin D once daily, the standard of care

Treatment:

Dietary Supplement: Vitamin D