Research Article: Impact of reduced dose of ready-to-use therapeutic foods in children with uncomplicated severe acute malnutrition: A randomised non-inferiority trial in Burkina Faso

Date Published: August 27, 2019

Publisher: Public Library of Science

Author(s): Suvi T. Kangas, Cécile Salpéteur, Victor Nikièma, Leisel Talley, Christian Ritz, Henrik Friis, André Briend, Pernille Kaestel, Lars Åke Persson

Abstract: BackgroundChildren 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 findingsWe 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.ConclusionsReducing 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 registrationISRCTN registry ISRCTN50039021.

Partial Text: Worldwide, 19 million children under 5 years of age suffer from severe acute malnutrition (SAM), contributing to over 500,000 deaths per year [1]. According to the World Health Organization (WHO) guidelines for community-based management of acute malnutrition (CMAM), children without medical complications at admission are treated as outpatients, with weekly checkup visits [2]. Treatment consists of a systematic antibiotic regimen, as well as a ready-to-use therapeutic food (RUTF), prescribed according to the weight of the child and continued until discharge [2].

From October 17, 2016, to July 20, 2018, 1,186 children were diagnosed with SAM and assessed for eligibility at 10 study sites. Of these, 802 (68%) children were eligible for the study and randomised to standard or reduced RUTF dose (Fig 1). One child was excluded after randomisation for not meeting the SAM criteria at admission. Therefore, 801 patients were included in the trial: 402 in the reduced dose and 399 in the standard dose arm. Thirteen children defaulted or were referred immediately after admission; four and nine in reduced and standard dose arms, respectively. Three children developed oedema (two in reduced and one in standard dose arm) and were excluded from weight gain calculation. Only recovered children continued to the post-discharge follow-up, contributing to the post-discharge outcome analyses including relapse rate (Fig 1).

Evidence is needed to inform policy on the optimisation of treatment of uncomplicated SAM. The current trial investigated the efficacy of reducing the RUTF dose after two weeks and showed that there was no effect on the total weight or MUAC gain velocity, recovery, or LoS in treatment. However, the linear growth of children receiving the reduced dose was significantly slower, particularly among the youngest group of <12-month-old children. Source: http://doi.org/10.1371/journal.pmed.1002887

 

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