title: Serum 25-hydroxyvitamin D response to vitamin D3 supplementation 50,000 IU monthly in youth with HIV-1 infection.
abstract: BACKGROUND
  Vitamin D deficiency and insufficiency occur frequently in youth with HIV infection, particularly among those receiving the antiretroviral drug efavirenz. Optimal vitamin D dosing for treatment is unclear.
  
  
  OBJECTIVE
  Our objective was to evaluate safety and measure change in 25-hydroxyvitamin D (25-OHD) concentration from baseline to study wk 4 and 12 during treatment with vitamin D(3), 50,000 IU monthly.
  
  
  METHODS
  We conducted a randomized double-blind, placebo-controlled multicenter trial of HIV-infected youth ages 18-24 yr, with viral load below 5000 copies/ml, on stable antiretroviral therapy.
  
  
  METHODS
  INTERVENTION included vitamin D(3), 50,000 IU (n = 102), or matching placebo (n = 101) administered in three directly observed oral doses at monthly intervals.
  
  
  RESULTS
  At baseline, mean (sd) age was 20.9 (2.0) yr; 37% were female and 52% African-American, and 54% were vitamin D deficient/insufficient (25-OHD < 20 ng/ml), with no randomized group differences. Of evaluable participants vitamin D deficient/insufficient at baseline who were administered vitamin D, 43 of 46 (93%) had sufficient 25-OHD by wk 12. Vitamin D supplementation increased 25-OHD serum concentration from a baseline of 21.9 (13.3) to 35.9 (19.1) ng/ml at wk 12 (P < 0.001) with no change for placebo. Although use of the antiretroviral efavirenz was associated with lower baseline 25-OHD concentration, efavirenz did not diminish the response to vitamin D supplementation. There was no treatment-related toxicity.
  
  
  CONCLUSIONS
  Supplementation with vitamin D(3) 50,000 IU monthly for three doses was safe. Increases in 25-OHD occurred in treated participants regardless of antiretroviral regimen.
authors.affiliation: Pediatric Infectious Diseases, Suite C450, P.O. Box 1997, Milwaukee, Wisconsin 53201-1997, USA. phavens@mcw.edu
authors.forename: Peter L
authors.initials: PL
authors.lastname: Havens
authors.forename: Kathleen
authors.initials: K
authors.lastname: Mulligan
authors.forename: Rohan
authors.initials: R
authors.lastname: Hazra
authors.forename: Patricia
authors.initials: P
authors.lastname: Flynn
authors.forename: Brandy
authors.initials: B
authors.lastname: Rutledge
authors.forename: Marta D
authors.initials: MD
authors.lastname: Van Loan
authors.forename: Jorge
authors.initials: J
authors.lastname: Lujan-Zilbermann
authors.forename: Bill G
authors.initials: BG
authors.lastname: Kapogiannis
authors.forename: Craig M
authors.initials: CM
authors.lastname: Wilson
authors.forename: Charles B
authors.initials: CB
authors.lastname: Stephensen
mesh_terms: D000293:Adolescent; D002762:Cholecalciferol / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000150:complications*; D015497:HIV-1; D006801:Humans; D008297:Male; D016896:Treatment Outcome; D014807:Vitamin D / Q000031:analogs & derivatives* / Q000097:blood; D014808:Vitamin D Deficiency / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D014815:Vitamins / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D014815:Vitamins; D014807:Vitamin D; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D