Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
NCT ID: NCT06792370
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
3521 participants
INTERVENTIONAL
2025-05-31
2026-12-31
Brief Summary
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The main questions are:
1. Does treating children with moderate acute malnutrition using RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with RUSF?
2. Does treating children with uncomplicated severe acute malnutrition using a reduced dose of RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with a standard dose of RUFT?
Secondly, the study will investigate the effect of this alternative protocol compared to the standard protocol on cost-effectiveness, psychomotor development, weight and linear growth and incidence of relapses.
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Detailed Description
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Supplementation will be daily according to the child's weight for a maximum of 12 weeks, at which point the programmatic recovery assessment will be done. Those who recovered before or at this point will be subsequently followed up monthly for up to 3 months for sustained recovery assessment.
Follow-up visits will be done at the health center every week for children with SAM and every two weeks for children with MAM.
At each visit, anthropometric measurements will be performed; a morbidity questionnaire will be administered before the mother/caregiver receives the ration for the following period. For the measurement of adherence, mothers will be asked to bring back empty and unused sachets/packaging of supplements from the last visit. Questions will also be asked to the mother/caregiver on the difficulties encountered during consumption and the adverse events observed following the consumption of the supplements.
The evaluation of the psychomotor development will be performed in a subsample.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MAM RUTF
Participants with MAM in this arm will receive a dose of 500 kcal/kg/day of RUTF
ready-to-use therapeutic food (for children with MAM)
Each child with MAM will be supplemented with RUTF for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks.
MAM RUSF
Participants with MAM in this arm will receive a dose of 540 kcal/kg/day of RUSF
Ready-to-use supplementary food
Each child with MAM will be supplemented with RUSF for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks post recovery
SAM Reduced-dose RUTF 1 (R-RUTF 1)
Participants with SAM in this arm will receive a dose of 150-185 kcal/kg/day of RUTF until programmatic recovery
Ready to Use Therapeutic Food - Reduced dose 1
Each child with SAM will be treated with a reduced dose for a maximum of 12 weeks : dose of 150-185 kcal/kg/day of RUTF until programmatic recovery. He/she will be followed subsequently up to 24 weeks post recovery.
SAM Reduced-dose RUTF 2 (R-RUTF 2)
Participants with SAM in this arm will receive a dose of 150-185 kcal/kg/day of RUTF until the child is no longer severely malnourished and does not have nutritional oedema then 100-130 kcal/kg/day of RUTF until programmatic recovery
Ready to Use Therapeutic Food - Reduced dose 2
Each child with SAM will be treated with a reduced dose for a maximum of 12 weeks : dose of 150-185 kcal/kg/day of RUTF until the child is no longer severely malnourished and does not have nutritional oedema then 100-130 kcal/kg/day of RUTF until programmatic recovery. He/she will be followed subsequently up to 24 weeks post recovery.
SAM standard dose RUTF (S-RUTF)
Participants with SAM in this arm will receive the standard dose of RUTF according to the national protocol for the integrated management of acute malnutrition in Burkina Faso
Ready to Use Therapeutic Food - Standard dose
Each child with SAM will be treated with a standard dose (according to the national protocol for the integrated management of acute malnutrition in Burkina Faso) for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks post recovery.
Interventions
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ready-to-use therapeutic food (for children with MAM)
Each child with MAM will be supplemented with RUTF for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks.
Ready-to-use supplementary food
Each child with MAM will be supplemented with RUSF for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks post recovery
Ready to Use Therapeutic Food - Reduced dose 1
Each child with SAM will be treated with a reduced dose for a maximum of 12 weeks : dose of 150-185 kcal/kg/day of RUTF until programmatic recovery. He/she will be followed subsequently up to 24 weeks post recovery.
Ready to Use Therapeutic Food - Standard dose
Each child with SAM will be treated with a standard dose (according to the national protocol for the integrated management of acute malnutrition in Burkina Faso) for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks post recovery.
Ready to Use Therapeutic Food - Reduced dose 2
Each child with SAM will be treated with a reduced dose for a maximum of 12 weeks : dose of 150-185 kcal/kg/day of RUTF until the child is no longer severely malnourished and does not have nutritional oedema then 100-130 kcal/kg/day of RUTF until programmatic recovery. He/she will be followed subsequently up to 24 weeks post recovery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* (115 mm ≤ MUAC\< 125 mm and -3 SDs ≤ WLZ \< -2 SDs) OR
* (115 mm ≤ MUAC\< 125 mm and WLZ ≥ -2 SDs) OR
* (MUAC ≥ 125 mm and -3 SDs ≤ WLZ \< -2 SDs).
* Age: 6 to 59 months
* Parents' acceptance of biweekly visits until programme discharge and monthly visits for the post-programme follow up
* Anthropometric measures MUAC\< 115 mm or WLZ\< - 3 SDs;
* Age: 6-59 months;
* Parents' acceptance of weekly visits until programme discharge and monthly visits for the post-programme follow up.
Exclusion Criteria
* Medical complications requiring hospital treatment
* Presence of any congenital anomaly or underlying chronic disease that may affect growth or the risk of infection
* Presence of bilateral oedema
* History of allergies to peanuts, milk, or soya
* Relapse from MAM treatment or transfer from SAM treatment
* Children who have recently (\<2 months) taken part in a nutrition programme;
* Residence outside the study area
* Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.)
2. SAM
* Failure of appetite test
* Medical complications requiring hospital treatment
* Presence of any congenital anomaly or underlying chronic disease that may affect growth or the risk of infection
* Presence of bilateral oedema
* History of allergies to peanuts, milk or soya
* Relapse from MAM treatment or transfer from SAM treatment
* Children who have recently (\<2 months) taken part in a nutrition programme;
* Residence outside the study area;
* Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.)
6 Months
59 Months
ALL
No
Sponsors
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Bill and Melinda Gates Foundation
OTHER
Institut de Recherche en Sciences de la Sante, Burkina Faso
OTHER_GOV
Responsible Party
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Locations
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Institut de Recherche en Sciences de la Santé
Ouagadougou, KADIOGO, Burkina Faso
Countries
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Central Contacts
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Facility Contacts
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Seni KOUANDA, MD., PhD
Role: backup
Hermann Bienou LANOU, MD., PhD
Role: backup
Jerome W. SOME, MD., PhD
Role: backup
References
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Chang CY, Trehan I, Wang RJ, Thakwalakwa C, Maleta K, Deitchler M, Manary MJ. Children successfully treated for moderate acute malnutrition remain at risk for malnutrition and death in the subsequent year after recovery. J Nutr. 2013 Feb;143(2):215-20. doi: 10.3945/jn.112.168047. Epub 2012 Dec 19.
Bailey J, Lelijveld N, Khara T, Dolan C, Stobaugh H, Sadler K, Lino Lako R, Briend A, Opondo C, Kerac M, Myatt M. Response to Malnutrition Treatment in Low Weight-for-Age Children: Secondary Analyses of Children 6-59 Months in the ComPAS Cluster Randomized Controlled Trial. Nutrients. 2021 Mar 24;13(4):1054. doi: 10.3390/nu13041054.
Maru Y, Tamiru D, Baye K, Chitekwe S, Laillou A, Darsene H, Abdulai R, Worku M, Belachew T. Effect of a simplified approach on recovery of children 6-59 months with wasting in Ethiopia: A noninferiority, cluster randomized controlled trial. Matern Child Nutr. 2024 Oct;20(4):e13670. doi: 10.1111/mcn.13670. Epub 2024 May 27.
Singh AS, Kang G, Ramachandran A, Sarkar R, Peter P, Bose A. Locally made ready to use therapeutic food for treatment of malnutrition a randomized controlled trial. Indian Pediatr. 2010 Aug;47(8):679-86. doi: 10.1007/s13312-010-0100-8.
Nackers F, Broillet F, Oumarou D, Djibo A, Gaboulaud V, Guerin PJ, Rusch B, Grais RF, Captier V. Effectiveness of ready-to-use therapeutic food compared to a corn/soy-blend-based pre-mix for the treatment of childhood moderate acute malnutrition in Niger. J Trop Pediatr. 2010 Dec;56(6):407-13. doi: 10.1093/tropej/fmq019. Epub 2010 Mar 23.
Medoua GN, Ntsama PM, Ndzana AC, Essa'a VJ, Tsafack JJ, Dimodi HT. Recovery rate of children with moderate acute malnutrition treated with ready-to-use supplementary food (RUSF) or improved corn-soya blend (CSB+): a randomized controlled trial. Public Health Nutr. 2016 Feb;19(2):363-70. doi: 10.1017/S1368980015001238. Epub 2015 May 5.
LaGrone LN, Trehan I, Meuli GJ, Wang RJ, Thakwalakwa C, Maleta K, Manary MJ. A novel fortified blended flour, corn-soy blend "plus-plus," is not inferior to lipid-based ready-to-use supplementary foods for the treatment of moderate acute malnutrition in Malawian children. Am J Clin Nutr. 2012 Jan;95(1):212-9. doi: 10.3945/ajcn.111.022525. Epub 2011 Dec 14.
Griswold SP, Langlois BK, Shen Y, Cliffer IR, Suri DJ, Walton S, Chui K, Rosenberg IH, Koroma AS, Wegner D, Hassan A, Manary MJ, Vosti SA, Webb P, Rogers BL. Effectiveness and cost-effectiveness of 4 supplementary foods for treating moderate acute malnutrition: results from a cluster-randomized intervention trial in Sierra Leone. Am J Clin Nutr. 2021 Sep 1;114(3):973-985. doi: 10.1093/ajcn/nqab140.
Karakochuk C, van den Briel T, Stephens D, Zlotkin S. Treatment of moderate acute malnutrition with ready-to-use supplementary food results in higher overall recovery rates compared with a corn-soya blend in children in southern Ethiopia: an operations research trial. Am J Clin Nutr. 2012 Oct;96(4):911-6. doi: 10.3945/ajcn.111.029744. Epub 2012 Sep 5.
Ackatia-Armah RS, McDonald CM, Doumbia S, Erhardt JG, Hamer DH, Brown KH. Malian children with moderate acute malnutrition who are treated with lipid-based dietary supplements have greater weight gains and recovery rates than those treated with locally produced cereal-legume products: a community-based, cluster-randomized trial. Am J Clin Nutr. 2015 Mar;101(3):632-45. doi: 10.3945/ajcn.113.069807. Epub 2015 Jan 7.
Javan R, Kooshki A, Afzalaghaee M, Aldaghi M, Yousefi M. Effectiveness of supplementary blended flour based on chickpea and cereals for the treatment of infants with moderate acute malnutrition in Iran: A randomized clinical trial. Electron Physician. 2017 Dec 25;9(12):6078-6086. doi: 10.19082/6078. eCollection 2017 Dec.
Nikiema L, Huybregts L, Kolsteren P, Lanou H, Tiendrebeogo S, Bouckaert K, Kouanda S, Sondo B, Roberfroid D. Treating moderate acute malnutrition in first-line health services: an effectiveness cluster-randomized trial in Burkina Faso. Am J Clin Nutr. 2014 Jul;100(1):241-9. doi: 10.3945/ajcn.113.072538. Epub 2014 May 7.
Daures M, Phelan K, Issoufou M, Kouanda S, Sawadogo O, Issaley K, Cazes C, Seri B, Ouaro B, Akpakpo B, Mendiboure V, Shepherd S, Becquet R. New approach to simplifying and optimising acute malnutrition treatment in children aged 6-59 months: the OptiMA single-arm proof-of-concept trial in Burkina Faso. Br J Nutr. 2020 Apr 14;123(7):756-767. doi: 10.1017/S0007114519003258. Epub 2019 Dec 10.
Stephenson KB, Agapova SE, Hendrixson DT, Koroma AS, Manary MJ. An Optimized Dose of Therapeutic Feeding Results in Noninferior Growth in Midupper Arm Circumference Compared with a Standard Dose in Children in Sierra Leone Recovering from Acute Malnutrition. Curr Dev Nutr. 2021 Feb 2;5(2):nzab007. doi: 10.1093/cdn/nzab007. eCollection 2021 Feb.
James PT, Van den Briel N, Rozet A, Israel AD, Fenn B, Navarro-Colorado C. Low-dose RUTF protocol and improved service delivery lead to good programme outcomes in the treatment of uncomplicated SAM: a programme report from Myanmar. Matern Child Nutr. 2015 Oct;11(4):859-69. doi: 10.1111/mcn.12192. Epub 2015 Apr 7.
Cazes C, Phelan K, Hubert V, Boubacar H, Bozama LI, Sakubu GT, Senge BB, Baya N, Alitanou R, Kouame A, Yao C, Gabillard D, Daures M, Augier A, Anglaret X, Kinda M, Shepherd S, Becquet R. 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. EClinicalMedicine. 2023 Feb 28;58:101878. doi: 10.1016/j.eclinm.2023.101878. eCollection 2023 Apr.
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Olofin I, McDonald CM, Ezzati M, Flaxman S, Black RE, Fawzi WW, Caulfield LE, Danaei G; Nutrition Impact Model Study (anthropometry cohort pooling). Associations of suboptimal growth with all-cause and cause-specific mortality in children under five years: a pooled analysis of ten prospective studies. PLoS One. 2013 May 29;8(5):e64636. doi: 10.1371/journal.pone.0064636. Print 2013.
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Other Identifiers
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INV-016380-2
Identifier Type: -
Identifier Source: org_study_id
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