Optimising the dosage of ready-to-use therapeutic food in children with uncomplicated severe acute malnutrition in the Democratic Republic of the Congo: a non-inferiority, randomised controlled trial.

Autor:	Cazes C; National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Research Centre, University of Bordeaux, Bordeaux, France., Phelan K; The Alliance for International Medical Action (ALIMA), Paris, France., Hubert V; The Alliance for International Medical Action (ALIMA), Kamuesha, Democratic Republic of the Congo., Boubacar H; The Alliance for International Medical Action (ALIMA), Kamuesha, Democratic Republic of the Congo., Bozama LI; National Nutrition Programme (PRONANUT), Ministry of Health, Kinshasa, Democratic Republic of the Congo., Sakubu GT; Kamuesha Health Zone in the Kasaï Province, Ministry of Health, Kamuesha, Democratic Republic of the Congo., Senge BB; National Nutrition Programme (PRONANUT), Ministry of Health, Kinshasa, Democratic Republic of the Congo., Baya N; National Nutrition Programme (PRONANUT), Ministry of Health, Kinshasa, Democratic Republic of the Congo., Alitanou R; The Alliance for International Medical Action (ALIMA), Kamuesha, Democratic Republic of the Congo., Kouamé A; PACCI ANRS Research Programme, University Hospital of Treichville, Abidjan, Côte d'Ivoire., Yao C; PACCI ANRS Research Programme, University Hospital of Treichville, Abidjan, Côte d'Ivoire., Gabillard D; National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Research Centre, University of Bordeaux, Bordeaux, France., Daures M; National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Research Centre, University of Bordeaux, Bordeaux, France., Augier A; The Alliance for International Medical Action (ALIMA), Paris, France., Anglaret X; National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Research Centre, University of Bordeaux, Bordeaux, France., Kinda M; The Alliance for International Medical Action (ALIMA), Dakar, Senegal., Shepherd S; The Alliance for International Medical Action (ALIMA), Dakar, Senegal., Becquet R; National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Research Centre, University of Bordeaux, Bordeaux, France.
Jazyk:	angličtina
Zdroj:	EClinicalMedicine [EClinicalMedicine] 2023 Feb 28; Vol. 58, pp. 101878. Date of Electronic Publication: 2023 Feb 28 (Print Publication: 2023).
DOI:	10.1016/j.eclinm.2023.101878
Abstrakt:	Background: Current standard management of severe acute malnutrition uses ready-to-use therapeutic food (RUTF) at a single weight-based calculation resulting in an increasing amount of RUTF provided to the family as the child's weight increases during recovery. Using RUTF at a gradually reduced dosage as the child recovers could reduce costs while achieving similar growth response. Methods: We conducted an open-label, non-inferiority, randomised controlled trial in the Democratic Republic of the Congo. Children aged 6-59 months with a mid-upper-arm circumference (MUAC) of less than 115 mm or a weight-for-height z-score (WHZ) of less than -3 or bipedal oedema and without medical complication were randomly assigned (1:1 ratio) using a specially developed software and random blocks (size was kept confidential), to either the current standard treatment (increasing the RUTF amount with increasing weight) or the OptiMA strategy (decreasing the RUTF dose with increasing weight and MUAC). The main endpoint was proportion of children who achieved recovery over the 6 months follow up period, as defined as meeting the following criteria for two consecutive weeks after a minimum of 4 weeks' treatment: axillary temperature less than 37.5 °C, no bipedal oedema, and anthropometric improvement (either MUAC 125 mm or greater or WHZ -1.5 or higher). We performed analyses on the intention-to-treat (ITT) (all children) and per-protocol populations (participants who had a minimum prescription of 4 weeks' RUTF, received at least 90% of the total amount of RUTF they were supposed to receive as per the protocol, and had a maximum interval of 6 weeks between any two visits in the 6-month follow-up). The non-inferiority margin was 10%. This trial is registered at ClinicalTrials.gov, and is now closed NCT03751475. Findings: Between July 22, 2019, and January 20, 2020, 491 children were randomly assigned, of whom 482 were analysed (240 in the standard group and 242 in the OptiMA group). In the ITT analysis, 234 (98%) children in the standard group and 231 (96%) children in OptiMA recovered (difference 2.0%, 95% CI -2.0% to 6.4%). In the PP analysis, 234 (98%) children in the standard group and 228 (97%) in OptiMA recovered (difference 1.3%, 95% CI -2.3% to 5.1%). Sensitivity analyses applying the same anthropometric recovery criteria to each group also showed non-inferiority of the OptiMA strategy in ITT and PP analysis. Interpretation: This non-inferiority trial treating uncomplicated children with MUAC of less than 115 mm or a WHZ of less than -3 or bipedal oedema with decreasing RUTF dose as MUAC and weight increase demonstrated non-inferiority compared to the standard protocol in a highly food-insecure context in the Democratic Republic of the Congo. These findings add evidence on the safety of RUTF dose reduction with significant RUTF cost savings. Funding: Innocent Foundation and European Civil Protection and Humanitarian Aid Operations. Translation: For the French translation of the abstract see Supplementary Materials section. Competing Interests: K.P. serves on the Social Purposes Advisory Commission of Nutriset, a main producer of lipid-based nutrient supplement products. All other authors declare no competing interests. (© 2023 The Authors.)
Databáze:	MEDLINE
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