title: Vitamin D3 decreases parathyroid hormone in HIV-infected youth being treated with tenofovir: a randomized, placebo-controlled trial.
abstract: BACKGROUND
  The study goal was to determine the effect of vitamin D (VITD) supplementation on tubular reabsorption of phosphate (TRP), parathyroid hormone (PTH), bone alkaline phosphatase (BAP), and C-telopeptide (CTX) in youth infected with human immunodeficiency virus (HIV) receiving and not receiving combination antiretroviral therapy (cART) containing tenofovir disoproxil fumarate (TDF).
  
  
  METHODS
  This randomized, double-blind, placebo-controlled multicenter trial enrolled HIV-infected youth 18-25 years based on stable treatment with cART containing TDF (n = 118) or no TDF (noTDF; n = 85), and randomized within those groups to vitamin D3, 50 000 IU (n = 102) or placebo (n = 101), administered at 0, 4, and 8 weeks. Outcomes included change in TRP, PTH, BAP, and CTX from baseline to week 12 by TDF/noTDF; and VITD/placebo.
  
  
  RESULTS
  At baseline, VITD and placebo groups were similar except those on TDF had lower TRP and higher PTH and CTX. At week 12, 95% in the VITD group had sufficient serum 25-hydroxy vitamin D (25-OHD; ≥20 ng/mL), increased from 48% at baseline, without change in placebo (P < .001). PTH decreased in the TDF group receiving VITD (P = .031) but not in the noTDF group receiving VITD, or either placebo group. The decrease in PTH with VITD in those on TDF occurred with insufficient and sufficient baseline 25-OHD (mean PTH change, -7.9 and -6.2 pg/mL; P = .031 and .053, respectively).
  
  
  CONCLUSIONS
  In youth on TDF, vitamin D3 supplementation decreased PTH, regardless of baseline 25-OHD concentration.
  
  
  BACKGROUND
  NCT00490412.
authors.affiliation: Department of Pediatrics, Children's Research Institute, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, WI 53201-1997, USA. phavens@mcw.edu
authors.forename: Peter L
authors.initials: PL
authors.lastname: Havens
authors.forename: Charles B
authors.initials: CB
authors.lastname: Stephensen
authors.forename: Rohan
authors.initials: R
authors.lastname: Hazra
authors.forename: Patricia M
authors.initials: PM
authors.lastname: Flynn
authors.forename: Craig M
authors.initials: CM
authors.lastname: Wilson
authors.forename: Brandy
authors.initials: B
authors.lastname: Rutledge
authors.forename: James
authors.initials: J
authors.lastname: Bethel
authors.forename: Cynthia G
authors.initials: CG
authors.lastname: Pan
authors.forename: Leslie R
authors.initials: LR
authors.lastname: Woodhouse
authors.forename: Marta D
authors.initials: MD
authors.lastname: Van Loan
authors.forename: Nancy
authors.initials: N
authors.lastname: Liu
authors.forename: Jorge
authors.initials: J
authors.lastname: Lujan-Zilbermann
authors.forename: Alyne
authors.initials: A
authors.lastname: Baker
authors.forename: Bill G
authors.initials: BG
authors.lastname: Kapogiannis
authors.forename: Kathleen
authors.initials: K
authors.lastname: Mulligan
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000293:Adolescent; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods; D002762:Cholecalciferol / Q000008:administration & dosage*; D004311:Double-Blind Method; D004347:Drug Interactions; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D063065:Organophosphonates / Q000008:administration & dosage*; D010281:Parathyroid Hormone / Q000097:blood*; D010919:Placebos / Q000008:administration & dosage; D000068698:Tenofovir; D014815:Vitamins / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D063065:Organophosphonates; D010281:Parathyroid Hormone; D010919:Placebos; D014815:Vitamins; D002762:Cholecalciferol; D000068698:Tenofovir; D000225:Adenine