title: Leaf concentrate compared with skimmed milk as nutritional supplementation for HIV-infected children: a randomized controlled trial in Burundi.
abstract: The effectiveness of leaf concentrate powder (LCP) as a nutritional supplement was established in trials conducted among adolescent girls and pregnant women in India. Here we evaluate LCP, compared with skimmed milk powder (SMP), as a supplement for antiretroviral-naïve children living with HIV in a sub-Saharan African country.
  
  
  
  Randomized controlled, two-arm, 6-month trial comparing effects of isoproteic (5 g) LCP (10 g daily) and SMP (15 g daily) on HIV-1 viral load, CD4+ cell count/percentage, weight/height-for-age, general blood parameters, diarrhoea, respiratory and HIV-related opportunistic infections.
  
  
  
  Bujumbura and Kirundo, Burundi.
  
  
  
  Eighty-three HIV-positive, antiretroviral-naïve children aged 5-14 years: median (range) CD4+ count, 716 (361-1690) cells/mm3; log10 HIV-1 viral load, 4·39 (1·79-6·00).
  
  
  
  LCP was equivalent to SMP in relation to HIV-specific blood parameters and did not demonstrate superiority over SMP in relation to Hb. Three children in each arm (LCP, 7·1 % (3/42); SMP, 7·3 % (3/41)) proceeded to antiretroviral therapy because their CD4+ counts fell below 350 cells/mm3. Children in the LCP group reported higher levels of appetite and overall health at 6 months. There were no differences in clinical events or any other outcome measures. LCP was less palatable than SMP to the children in this population, but there were few negative perceptions of appearance, texture and taste.
  
  
  
  LCP appears to be equivalent to SMP as a nutritional supplement in this population, despite slightly lower palatability. In relation to viral load and CD4+ count, equivalence may indicate no effect in either group. Effectiveness relative to no supplementation remains to be determined.
authors.affiliation: 1Centre for Child & Adolescent Health,School of Social & Community Medicine,University of Bristol,Oakfield House,Oakfield Grove,Bristol BS8 2BN UK.
authors.forename: Simon M
authors.identifier: 0000-0002-1239-1681
authors.initials: SM
authors.lastname: Collin
authors.affiliation: 2Association pour la Promotion des Extraits Foliaires en Nutrition (APEF),Trigny,France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Leclercq
authors.affiliation: 3Institut National de Santé Publique (INSP),Bujumbura,Burundi.
authors.forename: Novat
authors.initials: N
authors.lastname: Twungubumwe
authors.affiliation: 4Medical and Molecular Virology Unit and EA-484 University Hospital Center and Medical School of Reims,Reims,France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Andréoletti
authors.affiliation: 2Association pour la Promotion des Extraits Foliaires en Nutrition (APEF),Trigny,France.
authors.forename: François-Christophe
authors.initials: FC
authors.lastname: Richardier
authors.affiliation: 5Department of Nutrition,University of Reims Champagne-Ardenne (URCA),Reims,France.
authors.forename: Eric
authors.initials: E
authors.lastname: Bertin
mesh_terms: D000293:Adolescent; D000818:Animals; D002063:Burundi; D018791:CD4 Lymphocyte Count; D002648:Child; D002675:Child, Preschool; D019587:Dietary Supplements; D005260:Female; D015658:HIV Infections; D006801:Humans; D008297:Male; D008892:Milk; D028321:Plant Preparations / Q000008:administration & dosage*
chemical_list: D028321:Plant Preparations
keywords: Burundi; HIV; Leaf concentrate; Milk powder; Paediatric