50
Participants
Start Date
February 15, 2023
Primary Completion Date
January 1, 2026
Study Completion Date
June 1, 2029
Placebo
Placebo is normal saline, given in the first 28 days after birth, prepared to have the same volume and appearance as vitamin D, which is a clear odorless solution.
800 IU/day vitamin D supplementation with feedings in the first 28 days after birth
800 IU/day Vitamin D supplementation until 400 IU/ day are provided as part of usual care. At that point the intervention becomes a supplement of 400 IU/day above that given with usual care. In this way all infants in the intervention group receive 800 IU/day of vitamin D total supplementation in the first 28 days after birth with feedings.
Usual Care
Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices
RECRUITING
The University of Texas Medical Branch, Galveston
The University of Texas Health Science Center, Houston
OTHER