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

Abstract

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 t...

Treatment of severe acute malnutrition with oat or standard ready-to-use therapeutic food: a triple-blind, randomised controlled clinical trial

“…Most of our subjects qualified for SAM on the basis of MUAC, rather than WLZ or oedema. Our graduation rates were consistent with those from outpatient feeding programmes in Ethiopia and Burkina Faso that included large numbers of children who were enrolled using MUAC criteria 25 26. While these studies used the same criteria for SAM treatment, these populations were not equivalent in their severity of SAM.…”

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 co-morbidities occurring during outpatient treatment has been highlighted as important risk factors of poor treatment outcomes [41].…”

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].…”