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 trialResearch in context
Summary: 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 gradual...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-04-01
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| Series: | EClinicalMedicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S258953702300055X |
| _version_ | 1811162658310717440 |
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| author | Cécile Cazes Kevin Phelan Victoire Hubert Harouna Boubacar Liévin Izie Bozama Gilbert Tshibangu Sakubu Bruno Bindamba Senge Norbert Baya Rodrigue Alitanou Antoine Kouamé Cyrille Yao Delphine Gabillard Maguy Daures Augustin Augier Xavier Anglaret Moumouni Kinda Susan Shepherd Renaud Becquet |
| author_facet | Cécile Cazes Kevin Phelan Victoire Hubert Harouna Boubacar Liévin Izie Bozama Gilbert Tshibangu Sakubu Bruno Bindamba Senge Norbert Baya Rodrigue Alitanou Antoine Kouamé Cyrille Yao Delphine Gabillard Maguy Daures Augustin Augier Xavier Anglaret Moumouni Kinda Susan Shepherd Renaud Becquet |
| author_sort | Cécile Cazes |
| collection | DOAJ |
| description | Summary: 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. |
| first_indexed | 2024-04-10T06:33:57Z |
| format | Article |
| id | doaj.art-4f09820b0de04a41bb1bb73bb4df3a1b |
| institution | Directory Open Access Journal |
| issn | 2589-5370 |
| language | English |
| last_indexed | 2024-04-10T06:33:57Z |
| publishDate | 2023-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EClinicalMedicine |
| spelling | doaj.art-4f09820b0de04a41bb1bb73bb4df3a1b2023-03-01T04:32:45ZengElsevierEClinicalMedicine2589-53702023-04-0158101878Optimising 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 trialResearch in contextCécile Cazes0Kevin Phelan1Victoire Hubert2Harouna Boubacar3Liévin Izie Bozama4Gilbert Tshibangu Sakubu5Bruno Bindamba Senge6Norbert Baya7Rodrigue Alitanou8Antoine Kouamé9Cyrille Yao10Delphine Gabillard11Maguy Daures12Augustin Augier13Xavier Anglaret14Moumouni Kinda15Susan Shepherd16Renaud Becquet17National 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, FranceThe Alliance for International Medical Action (ALIMA), Paris, FranceThe Alliance for International Medical Action (ALIMA), Kamuesha, Democratic Republic of the CongoThe Alliance for International Medical Action (ALIMA), Kamuesha, Democratic Republic of the CongoNational Nutrition Programme (PRONANUT), Ministry of Health, Kinshasa, Democratic Republic of the CongoKamuesha Health Zone in the Kasaï Province, Ministry of Health, Kamuesha, Democratic Republic of the CongoNational Nutrition Programme (PRONANUT), Ministry of Health, Kinshasa, Democratic Republic of the CongoNational Nutrition Programme (PRONANUT), Ministry of Health, Kinshasa, Democratic Republic of the CongoThe Alliance for International Medical Action (ALIMA), Kamuesha, Democratic Republic of the CongoPACCI ANRS Research Programme, University Hospital of Treichville, Abidjan, Côte d'IvoirePACCI ANRS Research Programme, University Hospital of Treichville, Abidjan, Côte d'IvoireNational 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, FranceNational 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, FranceThe Alliance for International Medical Action (ALIMA), Paris, FranceNational 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, FranceThe Alliance for International Medical Action (ALIMA), Dakar, SenegalThe Alliance for International Medical Action (ALIMA), Dakar, SenegalNational 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; Corresponding author. Bordeaux Population Health Centre, Team GHiGS, University of Bordeaux, Bordeaux 33076, France.Summary: 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.http://www.sciencedirect.com/science/article/pii/S258953702300055XSevere acute malnutritionChildrenReady-to-use therapeutic foodAfricaRandomized clinical trial |
| spellingShingle | Cécile Cazes Kevin Phelan Victoire Hubert Harouna Boubacar Liévin Izie Bozama Gilbert Tshibangu Sakubu Bruno Bindamba Senge Norbert Baya Rodrigue Alitanou Antoine Kouamé Cyrille Yao Delphine Gabillard Maguy Daures Augustin Augier Xavier Anglaret Moumouni Kinda Susan Shepherd Renaud Becquet 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 trialResearch in context EClinicalMedicine Severe acute malnutrition Children Ready-to-use therapeutic food Africa Randomized clinical trial |
| title | 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 trialResearch in context |
| title_full | 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 trialResearch in context |
| title_fullStr | 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 trialResearch in context |
| title_full_unstemmed | 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 trialResearch in context |
| title_short | 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 trialResearch in context |
| title_sort | 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 trialresearch in context |
| topic | Severe acute malnutrition Children Ready-to-use therapeutic food Africa Randomized clinical trial |
| url | http://www.sciencedirect.com/science/article/pii/S258953702300055X |
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