title: Immunologic effect of zinc supplementation in HIV-infected children receiving highly active antiretroviral therapy: a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  We conducted this study to assess the immunologic effect of daily 20 mg zinc supplementation for 24 weeks in HIV-infected children older than 6 months receiving highly active antiretroviral therapy (ART).
  
  
  METHODS
  Fifty-two HIV-infected children older than 6 months in whom ART was initiated were randomized to receive either 20 mg of zinc or placebo for a period of 24 weeks. Children underwent clinical examination, anthropometry, and laboratory evaluations: CD4% and count, viral load, and serum zinc level at baseline, 12 weeks, and 24 weeks. The primary outcome evaluated was CD4% value at the end of 12 and 24 weeks of study intervention in the enrolled children.
  
  
  RESULTS
  Of 52 children enrolled, 49 completed the study. The median CD4% value rose from 10% to 23% at 12 weeks and to 24.5% at 24 weeks in the zinc group, whereas in the placebo group, the value rose from 11% to 20% at 12 weeks and to 22% at 24 weeks (P = 0.188 for comparison between the zinc and the placebo group at 12 wk and P = 0.3 for comparison at 24 wk). The median (interquartile range) log reductions in the viral load at 12 weeks in the 2 arms were similar at 12 (P = 0.84) and 24 weeks (P = 0.43).
  
  
  CONCLUSIONS
  Supplementation of 20 mg zinc daily for 24 weeks did not have any statistically significant effect on the increase in CD4%, decrease in viral load, anthropometric indices, and morbidity profile in HIV-infected children started on ART.
authors.affiliation: Departments of *Pediatrics; and †Microbiology, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Rakesh
authors.initials: R
authors.lastname: Lodha
authors.forename: Nipam
authors.initials: N
authors.lastname: Shah
authors.forename: Nivedita
authors.initials: N
authors.lastname: Mohari
authors.forename: Aparna
authors.initials: A
authors.lastname: Mukherjee
authors.forename: Madhu
authors.initials: M
authors.lastname: Vajpayee
authors.forename: Ravinder
authors.initials: R
authors.lastname: Singh
authors.forename: Mohit
authors.initials: M
authors.lastname: Singla
authors.forename: Savita
authors.initials: S
authors.lastname: Saini
authors.forename: Shinjini
authors.initials: S
authors.lastname: Bhatnagar
authors.forename: Sushil Kumar
authors.initials: SK
authors.lastname: Kabra
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D009752:Nutritional Status; D019562:Viral Load; D015032:Zinc / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D015032:Zinc