title: A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial.
abstract: To determine the optimal dose of vitamin D supplementation to achieve biochemical vitamin D sufficiency in extremely low gestational age newborns in a masked randomized controlled trial.
  
  
  
  100 infants 23 0/7-27 6/7 weeks gestation were randomized to vitamin D intakes of placebo (n = 36), 200 IU (n = 34), and 800 IU/d (n = 30) (approximating 200, 400, or 1000 IU/d, respectively, when vitamin D routinely included in parenteral or enteral nutrition is included). The primary outcomes were serum 25-hydroxy vitamin D concentrations on postnatal day 28 and the number of days alive and off respiratory support in the first 28 days.
  
  
  
  At birth, 67% of infants had 25-hydroxy vitamin D <20 ng/mL suggesting biochemical vitamin D deficiency. Vitamin D concentrations on day 28 were (median [25th-75th percentiles], ng/mL): placebo: 22 (13-47), 200 IU: 39 (26-57), 800 IU: 84.5 (52-99); P < .001. There were no differences in days alive and off respiratory support (median [25th-75th percentiles], days): placebo: 1 (0-11), 200 IU: 0 (0-8), and 800 IU: 0.5 (0-22); P = .63, or other respiratory outcomes among groups.
  
  
  
  At birth, most extremely preterm infants have biochemical vitamin D deficiency. This biochemical deficiency is reduced on day 28 by supplementation with 200 IU/d and prevented by 800 IU/d. Larger trials are required to determine if resolution of biochemical vitamin D deficiency improves clinical outcomes.
  
  
  
  ClinicalTrials.gov: NCT01600430.
authors.affiliation: Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.
authors.forename: Prem
authors.initials: P
authors.lastname: Fort
authors.affiliation: Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.
authors.forename: Ariel A
authors.initials: AA
authors.lastname: Salas
authors.affiliation: Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.
authors.forename: Teodora
authors.initials: T
authors.lastname: Nicola
authors.affiliation: Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.
authors.forename: Carolyne M
authors.initials: CM
authors.lastname: Craig
authors.affiliation: Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.
authors.forename: Waldemar A
authors.initials: WA
authors.lastname: Carlo
authors.affiliation: Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL. Electronic address: nambalavanan@peds.uab.edu.
authors.forename: Namasivayam
authors.initials: N
authors.lastname: Ambalavanan
mesh_terms: D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D062071:Infant, Extremely Premature; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000188:drug therapy*; D008297:Male; D012138:Respiratory Therapy; D014807:Vitamin D / Q000008:administration & dosage* / Q000031:analogs & derivatives / Q000097:blood; D014808:Vitamin D Deficiency / Q000188:drug therapy*; D014815:Vitamins / Q000008:administration & dosage*
chemical_list: D014815:Vitamins; D014807:Vitamin D; C104450:25-hydroxyvitamin D
keywords: bronchopulmonary dysplasia; intraventricular hemorrhage; necrotizing enterocolitis; premature infant; randomized trial; retinopathy of prematurity; septicemia