ViDES Trial (Vitamin D Extra Supplementation)
Vitamin D Deficiency
About this trial
This is an interventional other trial for Vitamin D Deficiency focused on measuring Premature infant, Vitamin D
Eligibility Criteria
Inclusion Criteria:
- Infants born at < 28 weeks gestational age (GA) or <1000 grams birth weight (BW)
- Inborn
- Informed written consent in an Institutional Review Board (IRB)-approved manner
Exclusion Criteria:
- GA >32 weeks regardless of birth weight (BW)
- Any major congenital anomaly
- An overt congenital nonbacterial infection
- Prenatal diagnosis of disorders that affect vitamin D absorption (e.g, cystic fibrosis)
- Such severe illness or immaturity that the attending neonatologist judges intensive care to be unjustified.
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Usual care plus placebo
Usual care plus vitamin D supplementation
Infants will receive placebo (normal saline) in the first 28 days after birth. 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.
Infants will receive cholecalciferol 800 IU/day in the first 28 days after birth, given enterally four times per day (0.5mL per dose = 200 IU) until the infant is provided 400 IU/day (when feedings reach about 120 -160 mL/kg/day). At that point the study cholecalciferol will be reduced to 400 IU/day for a total supplementation of 800 IU/day.