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

Abstract

ObjectiveTo 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).MethodsIn 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).ResultsRecovery 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.ConclusionsThis 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 numberNCT01705769; Pre-results.

Potential consequences of expanded MUAC-only programs on targeting of acutely malnourished children and ready-to-use-therapeutic-food allocation: lessons from cross-sectional surveys

“…The expected consequence of this would be to treat them with a lower RUTF dose, without routine medical treatment, and with a lesser level of medical assessment and follow-up, which may affect treatment outcomes Although currently available evidence on this topic is limited, a RUTF dose meeting total daily nutritional requirements may improve recovery and prevent relapse compared to RUTF given as a supplement to the usual diet [38]. Recent studies involving uncomplicated SAM patients reported important incidence of co-morbidities and referrals to hospital during the treatment period, thereby highlighting the importance of keeping these patients under close medical attention [39,40]. Failure to adequately address comorbidities occurring during outpatient treatment has been highlighted as important risk factors of poor treatment outcomes [41].…”

Undernutrition and severe acute malnutrition in children

“…However, 40% of children showed no recovery even after 16 weeks of use of RUTF. 33 A Cochrane review published in 2013 (8 randomised controlled trials, 10 037 children) reported that lipid based therapeutic foods and specially formulated foods such as corn-soy blended foods are effective in treatment of moderate acute malnutrition. However, no study evaluated the impact of improving the local diet to increase its nutritional content.…”

Foregrounding ‘Community’ in Community Management of Severe Acute Malnutrition

“…Meanwhile, the results of a rigorous trial involving supervised feeding with three different types of supplements [including commercial RUTF] have recently been published. This trial suggests that the gains across the arms were transient once the intervention was withdrawn (10,16) The same trial also showed that the difference in efficacy between augmented home foods and commercial RUTF was not significant, while a locally produced RUTF, identical in composition to the commercial RUTF, was inexplicably superior. Regardless of the product, significantly, supervised feeding was required to achieve good outcomes.…”

“…While it has taken the cover of 'lack of evidence' as its justification, it has been equally slow to take cognizance of the evidence as it emerges. Rather than creating whatever evidence-base is currently lacking to address the issue of how to empower communities to take charge of the nutrition of their own children better, it is engaged in promoting a reliance on technical, top-down measures of only marginally greater efficacy in the short term (10,13,16). It has also steadfastly refused to recognize the opportunity costs of pushing for an elusive 'cure' at the constant expense of prevention (17,18) and ignored concerns related to impacts upon health in the long term with products like RUTF (14) that are high in sugar.…”

“…This has also been postulated more recently by academics theoretically, arguing that India suffers a kind of malnutrition that is somewhat peculiar, being 'acute-on-chronic' rather than purely 'acute' (9). Not only does this have implications for the understanding of its determinants, it also seems to have an effect on relative mortalities and morbidities, as seen in two rigorous studies of large-scale CMAM interventions in India of the primarily medical typology (1,10). While resulting in lower mortalities, it also makes recovery more difficult and far lower recovery rates are seen as compared to Africa with similar interventions (11).…”