Leisel Talley, Suvi T. Kangas, Henrik Friis, Cécile Salpéteur, Victor Nikièma, Pernille Kæstel, Christian Ritz, André Briend, Lääketieteen ja terveysteknologian tiedekunta - Faculty of Medicine and Health Technology, and Tampere University
Background Children with uncomplicated severe acute malnutrition (SAM) are treated at home with ready-to-use therapeutic foods (RUTFs). The current RUTF dose is prescribed according to the weight of the child to fulfil 100% of their nutritional needs until discharge. However, there is doubt concerning the dose, as it seems to be shared, resulting in suboptimal cost-efficiency of SAM treatment. We investigated the efficacy of a reduced RUTF dose in community-based treatment of uncomplicated SAM. Methods and findings We undertook a randomised trial testing the non-inferiority of weight gain velocity of children with SAM receiving (a) a standard RUTF dose for two weeks, followed by a reduced dose thereafter (reduced), compared with (b) a standard RUTF dose throughout the treatment (standard). A mean difference of 0.0 g/kg/day was expected, with a non-inferiority margin fixed at −0.5 g/kg/day. Linear and logistic mixed regression analyses were performed, with study site and team as random effects. Between October 2016 and July 2018, 801 children with uncomplicated SAM aged 6–59 months were enrolled from 10 community health centres in Burkina Faso. At admission, the mean age (± standard deviation [SD]) was 13.4 months (±8.7), 49% were male, and the mean weight was 6.2 kg (±1.3). The mean weight gain velocity from admission to discharge was 3.4 g/kg/day and did not differ between study arms (Δ 0.0 g/kg/day; 95% CI −0.4 to 0.4; p = 0.92) confirming non-inferiority (p = 0.013). However, after two weeks, the weight gain velocity was significantly lower in the reduced dose with a mean of 2.3 g/kg/day compared with 2.7 g/kg/day in the standard dose (Δ −0.4 g/kg/day; 95% CI −0.8 to −0.02; p = 0.041). The length of stay (LoS) was not different (p = 0.73) between groups with a median of 56 days (interquartile range [IQR] 35–91) in both arms. No differences were found between reduced and standard arm in recovery (52.7% and 55.4%; p = 0.45), referral (19.2% and 20.1%; p = 0.80), defaulter (12.2% and 8.5%; p = 0.088), non-response (12.7% and 12.5%; p = 0.95), and relapse (2.4% and 1.8%; p = 0.69) rates, respectively. However, the reduced RUTF dose had a small 0.2 mm/week (95% CI 0.04 to 0.4; p = 0.015) negative effect on height gain velocity with a mean height gain of 2.6 mm/week with reduced and 2.8 mm/week with standard RUTF dose. The impact was more pronounced in children under 12 months of age (interaction, p = 0.019) who gained 2.8 mm/week with reduced and 3.1 mm/week with standard dose (Δ −0.4 mm/week; 95% CI −0.6 to −0.2; p < 0.001). Limitations include not blinding participants to the RUTF dose received and excluding all children with negative appetite test. The results are generalisable for relatively food secure contexts with a young SAM population. Conclusions Reducing the RUTF dose provided to children with SAM after two weeks of treatment did not reduce overall weight or mid-upper arm circumference (MUAC) gain velocity nor affect recovery or lengthen treatment time. However, it led to a small but significant negative effect on linear growth, especially among the youngest. The potential effect of reducing the RUTF dose in a routine program on treatment outcomes should be evaluated before scaling up. Trial registration ISRCTN registry ISRCTN50039021., Suvi Kangas and colleagues reveal a lowered dose of ready-to-use therapeutic food for malnourished children does not reduce weight gain, but can reduce linear growth., Author summary Why was this study done? Severe acute malnutrition (SAM) affects 19 million children worldwide and is treated with ready-to-use therapeutic foods (RUTFs). The current RUTF formulation and dosage are based on an inpatient treatment model and aim at achieving fast weight gain and recovery. However, when used in a home-based setting, the RUTF dose prescribed is often considered too large, resulting in sharing and a suboptimal cost-efficiency of SAM treatment. We sought to investigate the efficacy of reducing the RUTF dosage used in community-based treatment of uncomplicated SAM. What did the researchers do and find? We conducted a randomised controlled trial testing the non-inferiority of a reduced RUTF dose in the management of uncomplicated SAM compared with standard dose. This was called the MANGO trial. We enrolled 801 children 6–59 months of age and randomised them individually into receiving (1) a standard dose of RUTF throughout the treatment and (2) a standard dose during the first two weeks, followed by a reduced dose from third treatment week onwards. The trial showed non-inferior weight gain velocity from admission to discharge and similar recovery and length of stay in treatment. However, the reduced dose also resulted in a significantly slower height gain velocity compared with the standard dose. What do these findings mean? Our findings suggest that the reduction of the RUTF dose after the first two weeks results in similar weight gain velocity and recovery rates as with the standard dose given throughout SAM treatment. However, the reduced RUTF dose seems to slow down the height gain velocity of children and might thus not be fully optimal for children’s healthy growth. The reduced dose approach should be tested in a routine programmatic setting and in different food security contexts before scale-up.