title: Iron supplementation in HIV-infected Malawian children with anemia: a double-blind, randomized, controlled trial.
abstract: BACKGROUND
  It is unknown whether iron supplementation in human immunodeficiency virus (HIV)-infected children living in regions with high infection pressure is safe or beneficial. A 2-arm, double-blind, randomized, controlled trial was conducted to examine the effects of iron supplementation on hemoglobin, HIV disease progression, and morbidity.
  
  
  METHODS
  HIV-infected Malawian children aged 6-59 months with moderate anemia (hemoglobin level, 7.0-9.9 g/dL) were randomly assigned to receive 3 mg/kg/day of elemental iron and multivitamins (vitamins A, C, and D) or multivitamins alone for 3 months. Participants were followed for 6 months.
  
  
  RESULTS
  A total of 209 children were randomly assigned to treatment, and 196 (93.8%) completed 6 months of follow-up. Iron supplementation was associated with greater increases in hemoglobin concentrations (adjusted mean difference [aMD], 0.60; 95% confidence interval [CI], .06-1.13; P = .03) and reduced the risk of anemia persisting for up to 6 months follow-up (adjusted prevalence ratio, 0.59; 95% CI, .38-.92; P = .02). Children who received iron had a better CD4 percentage response at 3 months (aMD, 6.00; 95% CI, 1.84-10.16; P = .005) but an increased incidence of malaria at 6 months (incidence rate, 120.2 vs 71.7; adjusted incidence rate ratio [aIRR], 1.81 [95% CI, 1.04-3.16]; P = .04), especially during the first 3 months (incidence rate, 78.1 vs 36.0; aIRR, 2.68 [95% CI, 1.08-6.63]; P = .03).
  
  
  CONCLUSIONS
  Iron supplementation in anemic HIV-infected children has beneficial effects on hemoglobin, anemia, and immunity but increases the risk of malaria. Thus, iron supplementation in HIV-infected children living in malaria-endemic areas should only be provided in combination with adequate protection from malaria.
  
  
  BACKGROUND
  ISRCTN-62947977.
authors: Global Child Health Group-AIGHD, Emma Children's Hospital/Academic Medical Center.
authors: Michael O
authors: MO
authors: Esan
authors: Michael Boele
authors: MB
authors: van Hensbroek
authors: Ernest
authors: E
authors: Nkhoma
authors: Crispin
authors: C
authors: Musicha
authors: Sarah A
authors: SA
authors: White
authors: Feiko O
authors: FO
authors: Ter Kuile
authors: Kamija S
authors: KS
authors: Phiri
mesh_terms: D000328:Adult; D000740:Anemia / Q000188:drug therapy* / Q000469:parasitology / Q000821:virology*; D002675:Child, Preschool; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000097:blood* / Q000469:parasitology / Q000821:virology; D006801:Humans; D007223:Infant; D007501:Iron / Q000008:administration & dosage* / Q000009:adverse effects; D016778:Malaria, Falciparum / Q000097:blood / Q000469:parasitology / Q000821:virology; D008295:Malawi; D008297:Male; D009035:Mothers; D010963:Plasmodium falciparum / Q000302:isolation & purification; D012306:Risk; D014815:Vitamins / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D014815:Vitamins; D007501:Iron
keywords: HIV infection; Iron supplementation; anemia; children; malaria