ABSTRACT
Background:
Only 20% of children with severe acute malnutrition (SAM) have access to ready-to-use therapeutic food (RUTF), and RUTF cost limits its accessibility.
Methods:
This randomized, double-blind controlled study involved a clinical equivalence trial comparing the effectiveness of an alternative RUTF with standard RUTF in the home-based treatment of uncomplicated SAM and moderate malnutrition in Ghanaian children aged 6 to 59 months. The primary outcome was recovery, equivalence was defined as being within 5 percentage points of the control group, and an intention-to-treat analysis was used. Alternative RUTF was composed of whey protein, soybeans, peanuts, sorghum, milk, sugar, and vegetable oil. Standard RUTF included peanuts, milk, sugar, and vegetable oil. The cost of alternative RUTF ingredients was 14% less than standard RUTF. Untargeted metabolomics was used to characterize the bioactive metabolites in the RUTFs.
Results:
Of the 1,270 children treated for SAM or moderate malnutrition, 554 of 628 (88%) receiving alternative RUTF recovered (95% confidence interval [CI]=85% to 90%) and 516 of 642 (80%) receiving standard RUTF recovered (95% CI=77% to 83%). The difference in recovery was 7.7% (95% CI=3.7% to 11.7%). Among the 401 children with SAM, the recovery rate was 130 of 199 (65%) with alternative RUTF and 156 of 202 (77%) with standard RUTF (P=.01). The default rate in SAM was 60 of 199 (30%) for alternative RUTF and 41 of 202 (20%) for standard RUTF (P=.04). Children enrolled with SAM who received alternative RUTF had less daily weight gain than those fed standard RUTF (2.4 ± 2.4 g/kg vs. 2.9 ± 2.6 g/kg, respectively; P<.05). Among children with moderate wasting, recovery rates were lower for alternative RUTF, 386 of 443 (87%), than standard RUTF, 397 of 426 (93%) (P=.003). More isoflavone metabolites were found in alternative RUTF than in the standard.
Conclusion:
The lower-cost alternative RUTF was less effective than standard RUTF in the treatment of severe and moderate malnutrition in Ghana.
- Received: December 22, 2018.
- Accepted: April 2, 2019.
- Published: June 24, 2019.
- © Kohlmann et al.
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