Clinical trial NCT02404623: The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity
Official title: The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity During the First Year of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Preterm Infants
Vitamin D Deficiency
Bronchiolitis
Asthma
Pneumonia
Keywords: Vitamin D
Respiratory Morbidity
prematurity
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 33
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improved serum vitamin D levels in the intervention group (receiving 800 IU daily) in comparison to the control group (receiving 400 IU daily)
timeFrame: 12 months of age
Secondary outcomes:
measure: respiratory morbidity prevalence
timeFrame: first year
measure: respiratory morbidity prevalence
timeFrame: first year
measure: respiratory morbidity prevalence
timeFrame: first year
Other outcomes:
Locations:
city: Beer- Sheva
country: Israel
facility: Soroka University Medical Center
state: P.O.Box 151
Study officials:
affiliation: Soroka University Medical Center
name: Inbal Golan Tripto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.