Comparison of the effectiveness of a milk-free soy-maize-sorghum-based ready-to-use therapeutic food to standard ready-to-use therapeutic food with 25% milk in nutrition management of severely acutely malnourished Zambian children: an equivalence non-blinded cluster randomised controlled trial

Autor: Abel H. Irena, Victor O. Owino, Filippo Dibari, Max O Bachmann, Paluku Bahwere, Steve Collins, Clara Mbwili-Muleya, Elhadji Issakha Diop, Kate Sadler
Rok vydání: 2013
Předmět:
0301 basic medicine
Male
Pediatrics
medicine.medical_specialty
Arachis
Population
Severe Acute Malnutrition
Zambia
Weight Gain
Zea mays
03 medical and health sciences
0302 clinical medicine
medicine
Animals
Cluster Analysis
Humans
030212 general & internal medicine
Cluster randomised controlled trial
education
Sorghum
education.field_of_study
030109 nutrition & dietetics
Nutrition and Dietetics
business.industry
Public Health
Environmental and Occupational Health
Absolute risk reduction
Obstetrics and Gynecology
Infant
Original Articles
medicine.disease
Confidence interval
Infant Formula
Soy Milk
Malnutrition
Milk
Treatment Outcome
Equivalence Trial
Socioeconomic Factors
Therapeutic food
Child
Preschool
Pediatrics
Perinatology and Child Health
Fast Foods
Female
Milk Substitutes
business
Follow-Up Studies
Zdroj: Matern Child Nutr
ISSN: 1740-8709
Popis: 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
Databáze: OpenAIRE
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