Objective To assess the efficacy of ready-to-use therapeutic food (RUTF), centrally produced RUTF (RUTF-C) or locally prepared RUTF (RUTF-L) for home-based management of uncomplicated severe acute malnutrition (SAM) compared with micronutrient-enriched (augmented) energy-dense home-prepared foods (A-HPF, the comparison group).
Methods In an individually randomised multicentre trial, we enrolled 906 children aged 6–59 months with uncomplicated SAM. The children enrolled were randomised to receive RUTF-C, RUTF-L or A-HPF. We provided foods, counselling and feeding support until recovery or 16 weeks, whichever was earlier and measured outcomes weekly (treatment phase). We subsequently facilitated access to government nutrition services and measured outcomes once 16 weeks later (sustenance phase). The primary outcome was recovery during treatment phase (weight-for-height ≥−2 SD and absence of oedema of feet).
Results Recovery rates with RUTF-L, RUTF-C and A-HPF were 56.9%, 47.5% and 42.8%, respectively. The adjusted OR was 1.71 (95% CI 1.20 to 2.43; p=0.003) for RUTF-L and 1.28 (95% CI 0.90 to 1.82; p=0.164) for RUTF-C compared with A-HPF. Weight gain in the RUTF-L group was higher than in the A-HPF group (adjusted difference 0.90 g/kg/day, 95% CI 0.30 to 1.50; p=0.003). Time to recovery was shorter in both RUTF groups. Morbidity was high and similar across groups. At the end of the study, the proportion of children with weight-for-height Z-score (WHZ) >−2 was similar (adjusted OR 1.12, 95% CI 0.74 to 1.95; p=0.464), higher for moderate malnutrition (WHZ<−2 and ≥−3; adjusted OR 1.46, 95% CI 1.02 to 2.08; p=0.039), and lower for those with SAM (adjusted OR 0.58, 95% CI 0.40 to 0.85; p=0.005) in the RUTF-L when compared with the A-HPF group.
Conclusions This first randomised trial comparing options for home management of uncomplicated SAM confirms that RUTF-L is more efficacious than A-HPF at home. Recovery rates were lower than in African studies, despite longer treatment and greater support for feeding.
Trial registration number NCT01705769; Pre-results.
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Handling editor Valery Ridde
Collaborators Other members of the Study Group. SAS: Sowmya Prakash, Rimpi Kaushik, Gunjan Aggarwal, Rajkumari Suchitra, Priti Sharma. CMC: Kuryan George, Jasmine Helan Prasad, Venkatesan Sankarapandian, Preethi Ragasudha, Dulari Gupta. ARTH: Anandilal Sharma, Anjana Verma, Ashutosh Sharma, Trupti Patel, Priya Krishnan, Satyanarayan Panchal, Hitesh Rawal. Coordination Unit: Kiran Bhatia, Girish Chand Pant, Medha Shekhar.
Contributors All authors contributed substantially to the design and undertaking of the study, its analyses and writing of the manuscript. NB, SBM, AB, SDI, JM and RB designed the study. NB and ST coordinated the study and did data management and analysis, with technical support from RB, JM and SY. The following were responsible for the day-to-day implementation: SBM, SM and HSS (Delhi); AB, RAP and VRM (Vellore); and SDI, KI and VS (Udaipur). The study results were interpreted and the manuscript was prepared jointly during a workshop and has the final approval of all authors. NB affirms that the manuscript is an honest, accurate and transparent account of the study; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.
Funding The trial was funded by the Bill & Melinda Gates Foundation (grant number OPP1033634). The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit the publication.
Disclaimer The opinions expressed by them in this paper are their own and do not necessarily reflect the policy of the WHO.
Competing interests All authors have completed the Unified Competing Interest Form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that RB and SY are staff members of the WHO.
Ethics approval Society for Applied Studies, New Delhi; Christian Medical College, Vellore; Action Research and Training for Health, Udaipur; and the WHO Ethics Review Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The authors have a data sharing agreement between the participating sites and consent for data sharing was obtained from patients at recruitment. Reasonable requests for patient-level data should be made to the corresponding author and will be considered by the National Research Alliance for SAM that provided oversight to the study. The presented data are anonymised and the risk of identification is low.
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