Efficacy of three feeding regimens for home-based management of children with uncomplicated severe acute malnutrition: a randomised trial in India

Nita Bhandari, Sanjana Brahmawar Mohan, Anuradha Bose, Sharad D Iyengar, Sunita Taneja, Sarmila Mazumder, Ruby Angeline Pricilla, Kirti Iyengar, Harshpal Singh Sachdev, Venkata Raghava Mohan, Virendra Suhalka, Sachiyo Yoshida, Jose Martines, Rajiv Bahl, Nita Bhandari, Sanjana Brahmawar Mohan, Anuradha Bose, Sharad D Iyengar, Sunita Taneja, Sarmila Mazumder, Ruby Angeline Pricilla, Kirti Iyengar, Harshpal Singh Sachdev, Venkata Raghava Mohan, Virendra Suhalka, Sachiyo Yoshida, Jose Martines, Rajiv Bahl

Abstract

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.

Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Trial profile. A-HPF, micronutrient-enriched (augmented) energy-dense home-prepared foods; MUAC, mid-upper arm circumference; RUTF-C, centrally produced ready-to-use therapeutic food; RUTF-L, locally prepared ready-to-use therapeutic food; SAM, severe acute malnutrition.
Figure 2
Figure 2
Time to recovery in the three treatment groups. A-HPF, micronutrient-enriched (augmented) energy-dense home-prepared foods; RUTF-C, centrally produced ready-to-use therapeutic food; RUTF-L, locally prepared ready-to-use therapeutic food.

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