CompletedNot Applicable

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

Israel50 participantsStarted 2015-04

Plain-language 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.

Who can participate

Age range33 Weeks – 37 Weeks

SexALL

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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

What they're measuring

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

Trial details

NCT IDNCT02404623

SponsorSoroka University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-02-12

View on ClinicalTrials.gov More Other Preterm Infants trials