Acute Malnutrition With no ComplicationsAlternat-MALNCT06792370
Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
A study testing ready-to-use therapeutic food (for children with MAM), Ready-to-use supplementary food and Ready to Use Therapeutic Food - Reduced dose 1 in people with Acute Malnutrition With no Complications, run by Institut de Recherche en Sciences de la Sante, Burkina Faso at 1 site in Burkina Faso.
Trial summary
This experimental study aims to test an alternative protocol for managing acute malnutrition in children aged 6-59 months in Burkina Faso. This alternative protocol consists of using RUTF instead of RUSF for the management of moderate acute malnutrition and reduced-dose RUTF instead of standard-dose RUTF for the… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Acute Malnutrition With no Complications
- What is being tested?
- ready-to-use therapeutic food (for children with MAM), Ready-to-use supplementary food and Ready to Use Therapeutic Food - Reduced dose 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,521 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 26 Nov 2025to Nov 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Anthropometric measures:
- (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
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- 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.
Who cannot join
- 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
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- 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.)
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Burkina Faso1 site, 1 recruiting
- Recruiting
Institut de Recherche en Sciences de la Santé
Ouagadougou, KADIOGO
Hermann Biènou LANOU, MD., PhD, +226 66557580, hlanou@yahoo.ca
Seni KOUANDA, MD., PhD
About this study
Official title: Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition in Children Aged 6-59 Months in Burkina Faso: Reduced Dose of RUTF for SAM Children and RUTF Instead of RUSF for MAM Children
This experimental study aims to test an alternative protocol for managing acute malnutrition in children aged 6-59 months in Burkina Faso. This alternative protocol consists of using RUTF instead of RUSF for the management of moderate acute malnutrition and reduced-dose RUTF instead of standard-dose RUTF for the treatment of severe acute malnutrition.
The main questions are:
Read more
- 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?
- 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.
Read the detailed description
In this trial, children presenting at the health center and fulfilling the inclusion criteria will be randomly allocated into one of the study groups in a ratio of 1:1:1 for severe acute malnutrition (SAM) without complication and 1:1 for moderate acute malnutrition (MAM).
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
- Acute Malnutrition With no Complications
- Being tested
- ready-to-use therapeutic food (for children with MAM), Ready-to-use supplementary food, Ready to Use Therapeutic Food - Reduced dose 1, Ready to Use Therapeutic Food - Standard dose, Ready to Use Therapeutic Food - Reduced dose 2
- Keywords
- Effectiveness, acute malnutrition, management, treatment, reduced dose, Ready-to-Use Supplementary Foods, Ready-to-Use Therapeutic Foods, uncomplicated, without complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ready-to-use therapeutic food (for children with MAM)Dietary supplement
Also called RUTF
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 foodDietary supplement
Also called RUSF
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 1Dietary supplement
Also called R-RUTF 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 doseDietary supplement
Also called S-RUTF
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 2Dietary supplement
Also called R-RUTF 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.
| Study group | Role | What they receive |
|---|---|---|
| MAM RUTF | Experimental | Participants with MAM in this arm will receive a dose of 500 kcal/kg/day of RUTF Receives: Dietary Supplement: ready-to-use therapeutic food (for children with MAM) |
| MAM RUSF | Active comparator | Participants with MAM in this arm will receive a dose of 540 kcal/kg/day of RUSF Receives: Dietary Supplement: Ready-to-use supplementary food |
| SAM Reduced-dose RUTF 1 (R-RUTF 1) | Experimental | Participants with SAM in this arm will receive a dose of 150-185 kcal/kg/day of RUTF until programmatic recovery Receives: Dietary Supplement: Ready to Use Therapeutic Food - Reduced dose 1 |
| SAM Reduced-dose RUTF 2 (R-RUTF 2) | Experimental | 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 Receives: Dietary Supplement: Ready to Use Therapeutic Food - Reduced dose 2 |
| SAM standard dose RUTF (S-RUTF) | Active comparator | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of programmatic recovery
Number of children with a MUAC ≥ 125 mm and WLZ≥ -2 standard deviations for two consecutive visits at or before twelve (12) weeks since admission to the supplementation program in an arm divided by total number of children enrolled in the arm
Measured: From enrollment to the end of treatment (maximum 12 weeks)
Rate of sustained recovery
Number of children who maintain a MUAC ≥ 125 mm and WLZ≥ -2 SDs three (03) months after the programmatic recovery in an arm divided by total number of children with a programmatic recovery in the arm
Measured: from programmatic recovery to 3 months after
Secondary outcomes (11)
Cost per child treated
Economic metric obtained by dividing the total costs for an arm by the number of children who received treatment in this arm
Measured: From enrollment to the end of treatment (maximum 12 weeks)
Cost per child recovered
Economic metric obtained by dividing the total costs for an arm by the number of children recovered in this arm
Measured: From enrollment to the end of treatment (maximum 12 weeks)
Score of the extended version of Developmental Milestones Checklist (DMC-II)
Psychomotor development of children aged 6-23 months will be assessed by a tool adapted for sub-Saharan Africa countries settings : the extended version of Developmental Milestones Checklist (DMC-II). DMC-II have 76 items and each item is scored from 0 to 2 :zero if the child has not yet started doing the skill, one if the child has been able to perform the skill in the past four weeks but not continually, two if the child has been able to perform the skill for the past four weeks continually. Thus, the minimum value of this score is 0 (indicating no developmental milestones achieved) and the maximum is 152 (full developmental milestones achieved).Higher scores indicate better developmental outcomes, reflecting more advanced motor, language, and personal-social skills.
Measured: Three points : enrollment , exit of the supplementation program (up to 12 weeks) and exit of the study (3 months after recovery)
Daily weight gain
Refers to the increase in weight during the study period and is obtained by dividing the total weight gain in kilogram by the number of days since admission to the exit of the programme
Measured: From enrollment to the exit of the supplementation programme (maximum 12 weeks)]
Daily length gain
Refers to the increase in length during the study period and is obtained by dividing the total length gain in centimetre by the number of days since admission to the exit of the supplementation programme (maximum 12 weeks)
Measured: [Time Frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Energy intake
Daily average of calories per kilogram obtained from the 24-hour recall
Measured: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Rate of relapses
Number of children who return malnourished after programmatic recovery divided by the number of children with programmatic recovery
Measured: from programmatic recovery to 3 months after
Length of stay
Duration in days from admission to programmatic recovery
Measured: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Rate of defaulted
Number of children absent for three (3) consecutive visits in an arm divided of total number of children enrolled in the arm
Measured: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Rate of treatment failure
Number of participants with no weight gain after 5 weeks or at the third visit OR weight loss for more than 4 weeks in the program or at the second visit OR weight loss of more than 5% of body weight compared to admission weight at any time OR failure to meet discharge criteria after 3 months in an arm divided by total number of children enrolled in the arm
Measured: From enrollment to the end of treatment (maximum 12 weeks)
Number of adverse events
Number of incidents in which the use of the dietary supplement or data collection procedures is suspected to have contributed. This can be a physical event (e.g., a rash); a laboratory event (e.g., elevated blood sugar), or an increase in the severity or frequency of a pre-existing symptom or condition
Measured: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start26 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Acute Malnutrition With no ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individually randomized and controlled trial
- Masking
- None (open label)
- Enrolment
- 3,521 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche en Sciences de la Sante, Burkina Faso
- Sponsor type
- Other government
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792370
- Sponsor's protocol ID
- INV-016380-2
- Acronym
- Alternat-MAL
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23256140Bailey 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.
PubMed 33805040Maru 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.
PubMed 38800892Singh 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.
PubMed 20972285Nackers 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.
PubMed 20332221Medoua 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.
PubMed 25939394LaGrone 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.
PubMed 22170366Griswold 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.
PubMed 34020452Karakochuk 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.
PubMed 22952175Ackatia-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.
PubMed 25733649Javan 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.
PubMed 29560163Nikiema 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.
PubMed 24808482Daures 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.
PubMed 31818335Stephenson 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.
PubMed 33659773James 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.
PubMed 25850698