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Session: Nutritional Disparity and Efficacy/Effectiveness of Interventions/Programs in Children in Low-Income Countries (Oral 25)

(OR25-03-24) Efficacy of a Reduced Dose of Ready-to-Use Therapeutic Foods in the Management of Severe Acute Malnutrition: A Non-inferiority Randomized Controlled Trial

Monday, July 1, 2024
2:24 PM – 2:36 PM CT
Location:  W184
Objectives: In 2021, 10.4 million new cases of severe acute malnutrition (SAM) were reported, but less than 20% had access to treatment. Evidence has shown that a reduced dose of Ready-to-use Therapeutic Food (RUTF) during the treatment of children suffering from SAM is non inferior to a standard dose in a context of good food security. The aim of this study is to confirm the efficacy of a reduced dose of RUTF in the treatment of SAM under real conditions of care and food insecurity.

Methods: This is a non-inferiority randomized controlled trial (RCT) conducted in the Democratic Republic of Congo (DRC). Eligible children had to be SAM according to WHO criteria, with no medical complications and a positive appetite test. For the first two weeks, all children received the standard dosage of RUTF. From week 3 onwards, children in the intervention group received a reduced RUTF dose, 2 sachets/day for children over 7 kg and 1 sachet/day for those under 7 kg. The expected weight gain was 5g/kg/d, with a non-inferiority margin of 0.5g/kg/d. Differences between groups were investigated by a linear mixed-effects model using Stata v17. The study is registered with ISRCTN (https://www.isrctn.com/ISRCTN15258669).

Results: Between August and November 2021, after exclusion of outliers and missing data, 490 children on reduced dose and 478 on standard dose were included in the final analyses.

The two groups of children were similar on admission: mean age 29 months; 54.2% male; 44.3% with a Mid Upper Arm Circumference <115 mm; 22.7% with a Weight for Height < -3 Zscore; 7% with nutritional oedema and 95% living in a food-insecure household.

There was no significant difference in weight gain (Δ -0.03kg/kg/day; 95% IC -0.24 to 0.18) or MUAC gain (Δ -0.04mm/w; 95% IC -0.12 to 0.05).

The rate of recovery (74.3% under reduced dose and 74.1% under standard dose; p=0.98), of SAM relapse over 3 months (2.4% and 2.8%; p=0.74) and the length of stay with 42 versus 46 days (95% IC 35-56; 95% IC 35-56; p=084) were similar in both groups.

Conclusions: In the treatment of SAM without medical complications, a reduced dose of RUTF is non-inferior to the standard dose, in terms of weight gain velocity and performance indicators, in a context of severe food insecurity. Once scaled up, this strategy could improve access to SAM treatment in a country like the DRC.

Funding Sources: UK aid from the UK government and ACF & IdF Foundation