title: Safety and Efficacy of High-Dose Daily Vitamin D3 Supplementation in Children and Young Adults Infected With Human Immunodeficiency Virus.
abstract: BACKGROUND
  Suboptimal vitamin D (vitD) status is common in children and young adults infected with human immunodeficiency virus (HIV). The vitD supplemental dose needed to normalize vitD status in this population is unknown.
  
  
  METHODS
  In this double-blind trial, subjects infected with HIV ages 8.3 to 24.9 years were randomized to vitD3 supplementation of 4000 IU/day or 7000 IU/day and evaluated at 6 and 12 week for changes in vitD status and HIV indicators. A dose was considered unsafe if serum calcium was elevated (above age and sex-specific range) associated with elevated serum 25 hydroxyvitamin D (25(OH)D); >160 ng/mL).
  
  
  RESULTS
  At baseline, 95% of subjects (n = 44; 43% with perinatally acquired HIV, 57% with behaviorally acquired HIV) had a suboptimal serum 25(OH)D concentration of <32 ng/mL (mean ± standard deviation, 19.3 ± 7.4; range, 4.4-33.6 ng/mL). After 12 weeks (main outcome) of D3 supplementation, both D3 doses were safe and well tolerated, with no evidence of elevation of serum calcium concentrations or deterioration in HIV immunologic or virologic status. Sufficient vitD status, defined as serum 25(OH)D ≥32 ng/mL, was achieved in 81% of all subjects, and only the 7000 IU/day group (86%) achieved this a priori efficacy criterion in >80% of subjects. Change in serum 25(OH)D did not differ between HIV acquisition groups.
  
  
  CONCLUSIONS
  A 7000 IU/day D3 supplementation was safe and effective in children and young adults infected with HIV.
authors.affiliation: Division of Gastroenterology, Hepatology, and Nutrition, University of Pennsylvania Perelman School of Medicine, Children's Hospital of Philadelphia, Pennsylvania.
authors.forename: Kelly A
authors.initials: KA
authors.lastname: Dougherty
authors.affiliation: Division of Gastroenterology, Hepatology, and Nutrition, Children's Hospital of Philadelphia, Pennsylvania.
authors.forename: Joan I
authors.initials: JI
authors.lastname: Schall
authors.affiliation: Division of Gastroenterology, Hepatology, and Nutrition, University of Pennsylvania Perelman School of Medicine, Children's Hospital of Philadelphia, Pennsylvania.
authors.forename: Babette S
authors.initials: BS
authors.lastname: Zemel
authors.affiliation: Division of Allergy/Immunology, Department of Pediatrics, University of Pennsylvania Perelman School of Medicine, Children's Hospital of Philadelphia, Pennsylvania.
authors.forename: Florin
authors.initials: F
authors.lastname: Tuluc
authors.affiliation: University of Pennsylvania Perelman School of Medicine, Center for Clinical Epidemiology and Biostatistics, Biostatistics Analysis Center, Philadelphia, Pennsylvania.
authors.forename: Xiaoling
authors.initials: X
authors.lastname: Hou
authors.affiliation: Division of General Pediatrics, Department of Pediatrics, University of Pennsylvania Perelman School of Medicine, Children's Hospital of Philadelphia, Pennsylvania.
authors.forename: Richard M
authors.initials: RM
authors.lastname: Rutstein
authors.affiliation: Division of Gastroenterology, Hepatology, and Nutrition, University of Pennsylvania Perelman School of Medicine, Children's Hospital of Philadelphia, Pennsylvania.
authors.forename: Virginia A
authors.initials: VA
authors.lastname: Stallings
keywords: HIV; nutrition; pediatrics; supplementation; vitamin D.