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Soya, maize, and sorghum–based ready-to-use therapeutic food with amino acid is as efficacious as the standard milk and peanut paste–based formulation for the treatment of severe acute malnutrition in children: A noninferiority individually randomized controlled efficacy clinical trial in Malawi

par Bahwere, Paluku ;Collins, Steve;Akomo, Peter;Mwale, Mwawi;Murakami, Hitoshi;Banda, Chrissy;Kathumba, Sylvester;Banda, Chimwemwe;Jere, Solomon;Sadler, Kate
Référence The American journal of clinical nutrition, 106, 4, page (1100-1112)
Publication Publié, 2017-10

Article révisé par les pairs

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Résumé :

Background: Development of more cost-effective ready-to-use therapeutic food (RUTF) is a global public health priority. To date, previous lower-cost recipes have been less effective than the standard peanut and milk (PM)–based RUTF, particularly in children aged,24 mo. Objective: We aimed to compare the efficacy of the PM-RUTF to a milk-free soya, maize, and sorghum (FSMS)–RUTF enriched with crystalline amino acids without cow milk powder and a milk, soya, maize, and sorghum (MSMS)–RUTF containing 9.3% skim cow milk powder. Design: This nonblinded, 3-arm, parallel-group, simple randomized controlled trial enrolled Malawian children with severe acute malnutrition. Results: In intention-to-treat analyses, FSMS-RUTF showed noninferiority for recovery rates in children aged 24–59 mo (D: 21.9%; 95% CI: 29.5%, 5.6%) and 6–23 mo (D: 20.2%; 95% CI: 27.5%, 7.1%) compared with PM-RUTF. MSMS-RUTF also showed noninferiority for recovery rates in children aged 24–59 mo (D: 0.0%; 95% CI: 27.3%, 7.4%) and 6–23 mo (D: 0.6%; 95% CI: 24.3%, 5.5%). Noninferiority in recovery rates was also observed in per-protocol analyses. For length of stay in the program (time to cure), both FSMS-RUTF in children aged 24–59 mo (D: 2.8 d; 95% CI: 20.8, 6.5 d) and 6–23 mo (D: 3.4 d; 95% CI: 21.2, 8.0 d) and MSMS-RUTF in children aged 24–59 mo (D: 0.2 d; 95% CI: 23.1, 3.6 d) and 6–23 mo (D: 1.2 d; 95% CI: 23.4, 5.8 d) were not inferior to PM-RUTF. FSMS-RUTF was also significantly better than PM-RUTF at increasing hemoglobin and body iron stores in anemic children, with mean hemoglobin increases of 2.1 (95% CI: 1.6, 2.6) and 1.3 (95% CI: 0.9, 1.8) and mean body iron store increases of 2.0 (95% CI: 0.8, 3.3) and 0.1 (95% CI: 21.1, 1.3) for FSMS-RUTF and PM-RUTF, respectively. Conclusions: FSMS-RUTF without milk is efficacious in the treatment of severe acute malnutrition in children aged 6–23 and 24–59 mo. It is also better at correcting iron deficiency anemia than PM-RUTF. This trial was registered at www.pactr.org as PACTR201505001101224.