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Irena A.H.,Valid International | Bahwere P.,Valid International | Bahwere P.,Free University of Brussels | Owino V.O.,Valid Nutrition | And 6 more authors.
Maternal and Child Nutrition | Year: 2015

Community-based Management of Acute Malnutrition using ready-to-use therapeutic food (RUTF) has revolutionised the treatment of severe acute malnutrition (SAM). However, 25% milk content in standard peanut-based RUTF (P-RUTF) makes it too expensive. The effectiveness of milk-free RUTF has not been reported hitherto. This non-blinded, parallel group, cluster randomised, controlled, equivalence trial that compares the effectiveness of a milk-free soy-maize-sorghum-based RUTF (SMS-RUTF) with P-RUTF in treatment of children with SAM, closes the gap. A statistician randomly assigned health centres (HC) either to the SMS-RUTF (n=12; 824 enrolled) or P-RUTF (n=12; 1103 enrolled) arms. All SAM children admitted at the participating HCs were enrolled. All the outcomes were measured at individual level. Recovery rate was the primary outcome. The recovery rates for SMS-RUTF and P-RUTF were 53.3% and 60.8% for the intention-to-treat (ITT) analysis and 77.9% and 81.8% for per protocol (PP) analyses, respectively. The corresponding adjusted risk difference (ARD) and 95% confidence interval, were -7.6% (-14.9, 0.6%) and -3.5% (-9,6., 2.7%) for ITT (P=0.034) and PP analyses (P=0.257), respectively. An unanticipated interaction (interaction P<0.001 for ITT analyses and 0.0683 for PP analyses) between the study arm and age group was observed. The ARDs were -10.0 (-17.7 to -2.3)% for ITT (P=0.013) and -4.7 (-10.0 to 0.7) for PP (P=0.083) analyses for the <24 months age group and 2.1 (-10.3,14.6)% for ITT (P=0.726) and -0.6 (-16.1, 14.5) for PP (P=0.939) for the ≥24 months age group. In conclusion, the study did not confirm our hypothesis of equivalence between SMS-RUTF and P-RUTF in SAM management. © 2015 John Wiley & Sons, Ltd. Source

Bahwere P.,Valid International | Bahwere P.,Free University of Brussels | Banda T.,Valid International | Sadler K.,Valid International | And 5 more authors.
Maternal and Child Nutrition | Year: 2014

The cost of ready-to-use therapeutic food (RUTF) used in community-based management of acute malnutrition has been a major obstacle to the scale up of this important child survival strategy. The current standard recipe for RUTF [peanut-based RUTF (P-RUTF)] is made from peanut paste, milk powder, oil, sugar, and minerals and vitamins. Milk powder forms about 30% of the ingredients and may represent over half the cost of the final product. The quality of whey protein concentrates 34% (WPC34) is similar to that of dried skimmed milk (DSM) used in the standard recipe and can be 25-33% cheaper. This blinded, parallel group, randomised, controlled non-inferiority clinical trial tested the effectiveness in treating severe acute malnutrition (SAM) of a new RUTF formulation WPC-RUTF in which WPC34 was used to replace DSM. Average weight gain (non-inferiority margin Δ=-1.2gkg-1day-1) and recovery rate (Δ=-10%) were the primary outcomes, and length of stay (LOS) was the secondary outcome (Δ=+14days). Both per-protocol (PP) and intention-to-treat (ITT) analyses showed that WPC-RUTF was not inferior to P-RUTF for recovery rate [difference and its 95% confidence interval (CI) of 0.5% (95% CI -2.7, 3.7) in PP analysis and 0.6% (95% CI -5.2, 6.3) in ITT analysis] for average weight gain [0.2 (-0.5; 0.9) for both analyses] and LOS [-1.6days (95% CI, -4.6, 1.4days) in PP analysis and -1.9days (95% CI, -4.6, 0.8days) for ITT analysis]. In conclusion, whey protein-based RUTF is an effective cheaper alternative to the standard milk-based RUTF for the treatment of SAM. © 2014 John Wiley & Sons Ltd. Source

Dibari F.,Valid International | Dibari F.,University College London | Bahwere P.,Valid International | Huerga H.,MSF France Kenya | And 4 more authors.
Nutrition | Year: 2013

Objective: To develop a method for determining the acceptability and safety of ready-to-use therapeutic foods (RUTF) before clinical trialing. Acceptability was defined using a combination of three consumption, nine safety, and six preference criteria. These were used to compare a soy/maize/sorghum RUTF (SMS-RUTFh), designed for the rehabilitation of human immunodeficiency virus/tuberculosis (HIV/TB) wasted adults, with a peanut-butter/milk-powder paste (P-RUTF; brand: Plumpy'nut) designed for pediatric treatment. Methods: A cross-over, randomized, controlled trial was conducted in Kenya. Ten days of repeated measures of product intake by 41 HIV/TB patients, >18 y old, body mass index (BMI) 18-24 kg·m-2, 250 g were offered daily under direct observation as a replacement lunch meal. Consumption, comorbidity, and preferences were recorded. Results: The study arms had similar age, sex, marital status, initial BMI, and middle upper-arm circumference. No carryover effect or serious adverse events were found. SMS-RUTFh energy intake was not statistically different from the control, when adjusted for BMI on day 1, and the presence of throat sores. General preference, taste, and sweetness scores were higher for SMS-RUTFh compared to the control (P < 0.05). Most consumption, safety, and preference criteria for SMS-RUTFh were satisfied except for the average number of days of nausea (0.16 versus 0.09 d) and vomiting (0.04 versus 0.02 d), which occurred with a higher frequency (P < 0.05). Conclusion: SMS-RUTFh appears to be acceptable and can be safely clinically trialed, if close monitoring of vomiting and nausea is included. The method reported here is a useful and feasible approach for testing the acceptability of ready-to-use foods in low income countries. © 2013 Elsevier Inc. Source

Bahwere P.,Valid International | Bahwere P.,Free University of Brussels | Balaluka B.,Catholic University of Bukavu | Wells J.C.K.,University College London | And 5 more authors.
American Journal of Clinical Nutrition | Year: 2016

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-maizesorghum RUTF (SMS-RUTF) with that of standard peanut paste- based RUTF (P-RUTF). Design: 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 [D = 2.0 d (95% CI: -1.7, 5.8 d)] in children ·-4 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/m2 (95% CI: -0.3, 1.1 kg/m2); 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) and P = 0.034 for comparison between community controls and the SMS-RUTF group; Δ = -1.8 kg (95% CI: -2.9, -0.6 kg) and P = 0.003 for comparison between community controls and the P-RUTF group]. Conclusion: 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. © 2016 American Society for Nutrition. Source

Bisimwa G.,Free University of Brussels | Owino V.O.,Valid Nutrition | Bahwere P.,Valid International | Bahwere P.,Free University of Brussels | And 4 more authors.
American Journal of Clinical Nutrition | Year: 2012

Background: Evidence of the effectiveness of lipid-based ready-touse complementary foods (RUCF) at improving linear growth among infants aged 6-12 mo is scarce, and further work is warranted. Objective: The objective was to assess the effectiveness of a fortified soybean-maize-sorghum RUCF paste compared with a fortified corn soy blend (UNIMIX) porridge on the prevalence of underweight and stunting among infants in South Kivu Province, Democratic Republic of Congo. Design: Infants were randomly assigned at 6 mo of age to receive either RUCF (n = 691) or UNIMIX (n = 692) for 6 mo. In addition to admission and monthly anthropometric measurements, hemoglobin, triglyceride, and cholesterol were measured at enrollment and at the end of the study. Results: No significant differences in the prevalence of stunting (RUCF: 48.6%; UNIMIX: 46.4%; P = 0.31), the prevalence of underweight (RUCF: 20.4%; UNIMIX: 18.2%; P = 0.42), or weight gain (RUCF: 1.2 ± 0.7 kg; UNIMIX: 1.3 ± 0.7 kg; P = 0.08) were found. A small but statistically significant difference in length gain (RUCF: 5.2 ± 2.0; UNIMIX: 5.4 ± 2.0; P = 0.03) was found. No significant differences in the concentrations of hemoglobin, serum triglyceride, and serum cholesterol were found between the 2 groups. Conclusion: No significant differences were found between the RUCF and UNIMIX in the reduction of the prevalence of stunting and underweight at 12 mo of age among rural Congolese infants. This trial was registered at controlled-trials.com as ISRCTN20267635. © 2012 American Society for Nutrition. Source

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