title: Cereals and pulse-based ready-to-use therapeutic food as an alternative to the standard milk- and peanut paste-based formulation for treating severe acute malnutrition: a noninferiority, individually randomized controlled efficacy clinical trial.
abstract: BACKGROUND
  The cost of current standard ready-to-use therapeutic food (RUTF) is among the major obstacles to scaling up community-based management of acute malnutrition (CMAM), an important child survival strategy. Identifying a cheaper alternative is a global public health priority.
  
  
  OBJECTIVE
  We sought to compare the efficacy of soya-maize-sorghum RUTF (SMS-RUTF) with that of standard peanut paste-based RUTF (P-RUTF).
  
  
  METHODS
  We used a nonblinded, parallel-group, simple randomized controlled trial along with a day care approach that enrolled 2 groups of children aged 6-23 and 24-59 mo, respectively, with severe acute malnutrition (SAM).
  
  
  RESULTS
  Intention-to-treat (ITT) and per-protocol (PP) analyses showed noninferiority of SMS-RUTF compared with P-RUTF for the recovery rate [ITT: Δ = -2.0% (95% CI: -7.6%, 3.6%); PP: -1.9% (95% CI: -5.3%, 1.4%)], weight gain [Δ = -0.7 g · kg(-1)· d(-1)(95% CI: -1.3, 0.0 g · kg(-1)· d(-1))], and length of stay [Δ = 2.0 d (95% CI: -1.7, 5.8 d)] in children ≥24 mo of age. In children ≤23 mo of age, the recovery rate of SMS-RUTF was inferior to that of P-RUTF [ITT: Δ = -20.8% (95% CI: -29.9%, -11.7%); PP: -17.2% (95% CI: -25.6%, -8.7%)]. Treatment with SMS-RUTF resulted in a greater increase in hemoglobin [0.670 g/dL (95% CI: 0.420, 0.921 g/dL);P< 0.001]. Treatment with both RUTFs resulted in the replenishment of all of the amino acids tested except for methionine. There were no differences at discharge between RUTF groups in fat mass [Δ = 0.3 kg (95% CI: -0.6, 1.6 kg);P= 0.341] or fat mass index [Δ = 0.4 kg/m(2)(95% CI: -0.3, 1.1 kg/m(2));P= 0.262]. By contrast, comparisons of fat-free mass indicated lower concentrations than the community controls after treatment with either of the 2 RUTFs [Δ = -1.3 kg (95% CI: -2.4, -0.1 kg) andP= 0.034 for comparison between community controls and the SMS-RUTF group; Δ = -1.8 kg (95% CI: -2.9, -0.6 kg) andP= 0.003 for comparison between community controls and the P-RUTF group].
  
  
  CONCLUSIONS
  SMS-RUTF can be used to treat SAM in children aged ≥24 mo to reduce the costs of CMAM programs. More research is required to optimize SMS-RUTF for younger children. This trial was registered in the Pan African Clinical Trial Registry as PACTR201303000475166.
authors.affiliation: Valid International, Oxford, United Kingdom; Centre for Research in Epidemiology, Biostatistics and Clinical Research, School of Public Health, University of Brussels, Brussels, Belgium; paluku@validinternational.org.
authors.forename: Paluku
authors.initials: P
authors.lastname: Bahwere
authors.affiliation: Lwiro Natural Science Research Centre, South Kivu, Democratic Republic of Congo; College of Medicine, Catholic University of Bukavu, South Kivu, Democratic Republic of Congo;
authors.forename: Bisimwa
authors.initials: B
authors.lastname: Balaluka
authors.affiliation: Childhood Nutrition Research Centre, University College London Institute of Child Health, London, United Kingdom; and.
authors.forename: Jonathan C K
authors.initials: JC
authors.lastname: Wells
authors.affiliation: Lwiro Natural Science Research Centre, South Kivu, Democratic Republic of Congo;
authors.forename: Chobohwa N
authors.initials: CN
authors.lastname: Mbiribindi
authors.affiliation: Valid International, Oxford, United Kingdom;
authors.forename: Kate
authors.initials: K
authors.lastname: Sadler
authors.affiliation: Valid Nutrition, Cork, Ireland.
authors.forename: Peter
authors.initials: P
authors.lastname: Akomo
authors.affiliation: Centre for Research in Epidemiology, Biostatistics and Clinical Research, School of Public Health, University of Brussels, Brussels, Belgium;
authors.forename: Michèle
authors.initials: M
authors.lastname: Dramaix-Wilmet
authors.affiliation: Valid International, Oxford, United Kingdom;
authors.forename: Steve
authors.initials: S
authors.lastname: Collins
mesh_terms: D000596:Amino Acids / Q000032:analysis; D010367:Arachis; D001823:Body Composition; D002675:Child, Preschool; D004487:Edema / Q000178:diet therapy; D002523:Edible Grain / Q000737:chemistry*; D017097:Electric Impedance; D002149:Energy Intake; D057140:Fast Foods; D005260:Female; D005500:Follow-Up Studies; D005511:Food Handling; D006801:Humans; D007223:Infant; D007902:Length of Stay; D008297:Male; D041941:Milk Substitutes / Q000737:chemistry*; D000067011:Severe Acute Malnutrition / Q000178:diet therapy*; D012959:Socioeconomic Factors; D045868:Sorghum; D013025:Glycine max; D016896:Treatment Outcome; D015430:Weight Gain; D003313:Zea mays
chemical_list: D000596:Amino Acids
keywords: amino acid; bioimpedance analysis; cereals; deuterium oxide; efficacy; hemoglobin; milk; pulses; ready-to-use therapeutic food; severe acute malnutrition