180
Participants
Start Date
September 6, 2022
Primary Completion Date
August 12, 2025
Study Completion Date
December 1, 2027
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 (started when infants receive full feedings of about 120-160 mL/kg/day). 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
Care will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices. When the infant receives about 120 to 160 mL/kg/day of fortified milk at 24 kcal/ounce, the infant will receive supplementation with 400 IU/day of vitamin D as usual care.
The University of Texas Health Science Center at Houston, Houston
National Center for Advancing Translational Sciences (NCATS)
NIH
The Gerber Foundation
OTHER
The University of Texas Health Science Center, Houston
OTHER