Efficacy of Alternative RUTFs for Treatment of Child Wasting and Prevention of Relapse
Phase: PHASE3
Conditions: Severe Acute Malnutrition, Moderate Acute Malnutrition, Wasting
Sponsor: International Food Policy Research Institute

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Efficacy of alternative RUTFs for treatment of child wasting and prevention of relapse 
 
Institut de Recherche en Sciences de la Santé (investigator) 
AfricSanté (implementer) 
International Food Policy Research Institute (sponsor) 
 
Version 2.0; April 16, 2025 
NCT identifier: NCT06912620 
 
 

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Table of Contents 
List of abbreviations ...................................................................................................................................... 4 
List of tables .................................................................................................................................................. 5 
Abstract ......................................................................................................................................................... 6 
Introduction .................................................................................................................................................. 7 
Research objectives ....................................................................................................................................... 8 
Methodology ................................................................................................................................................. 9 
Study setting and site selection ................................................................................................................ 9 
Study design .............................................................................................................................................. 9 
Randomization procedure ........................................................................................................................ 9 
Study participants and determination of eligibility .................................................................................. 9 
Study intervention and control arms ...................................................................................................... 10 
Outcomes ................................................................................................................................................ 12 
Sample size.............................................................................................................................................. 14 
Study procedures .................................................................................................................................... 16 
Anthropometric and clinical procedures ............................................................................................ 16 
Costing ................................................................................................................................................ 16 
Acceptability sub-study ...................................................................................................................... 18 
Fecal sample analysis sub-study ......................................................................................................... 19 
Data management and confidentiality ................................................................................................... 21 
Statistical analysis ................................................................................................................................... 22 
Adverse event (AE) and serious adverse event (SAE) monitoring and reporting ................................... 22 
Early withdrawal from the study ............................................................................................................. 23 
Ethics ........................................................................................................................................................... 23 
Community engagement ........................................................................................................................ 23 
Voluntary and informed participation .................................................................................................... 23 
Risks and benefits ................................................................................................................................... 23 
AE/SAE response ..................................................................................................................................... 24 
Participant privacy and confidentiality ................................................................................................... 24 
Trial registration .......................................................................................................................................... 24 
Record keeping and Trial Master File (TMF) management ......................................................................... 24 
Dissemination .............................................................................................................................................. 25 

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Timeline summary ....................................................................................................................................... 25 
Budget summary ......................................................................................................................................... 25 
Roles of investigators .................................................................................................................................. 26 
References ................................................................................................................................................... 27 
 
 

4 
 
List of abbreviations 
 
 
 
 
ABC 
Activity-Based Costing  
CMAM 
Community Management of Acute Malnutrition 
CoC 
Continuum of Care 
CSPS 
Centre de Santé et Promotion Sociale 
DALY 
Disability-adjusted life year  
DSMC 
Data Safety and Monitoring Committee 
ELISA 
Enzyme-linked immunosorbent assay 
HAZ 
Height-for-age z-score 
IFPRI 
International Food Policy Research Institute 
IRB 
Institutional Review Board  
IRSS 
Institut de Recherche en Sciences de la Santé 
LAZ 
Length-for-Age Z-score 
MAM 
Moderate Acute Malnutrition 
NGO 
Non-governmental organization 
OTP 
Outpatient Treatment Program 
PP 
Per-protocol 
pp 
Percentage point 
RUSF 
Ready-to-Use Supplementary Food 
RUTF 
Ready-to-Use Therapeutic Food 
SAM 
Severe Acute Malnutrition 
SAP 
Statistical analysis plan 
SD 
Standard deviation 
SMS-RUTF 
Soy-maize-sorghum-based RUTF 
SOP 
Standard operating procedure 
S-RUTF 
Soy-based RUTF 
TMF 
Trial Master File 
UN 
United Nations 
UNICEF 
United Nations International Children's Emergency Fund 
WAZ 
Weight-for-Age Z-score 
WHO 
World Health Organization 
WHZ 
Weight-for-Height Z-sore 
WLZ 
Weight-for-Length Z-score 

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List of tables 
 
Table 1. Burkina Faso guidelines for dosage for MAM ................................................................................ 11 
Table 2. Burkina Faso guidelines for dosage for SAM.................................................................................. 11 
Table 3. Primary and secondary study outcomes ....................................................................................... 12 
Table 4. Sample size calculations ................................................................................................................. 14 
Table 5. Cost categories and their descriptions for costing analyses .......................................................... 17 
Table 6. Costing outcomes and their definitions ......................................................................................... 18 
Table 7. Study procedures and data collection schedule ............................................................................ 21 
Table 8. Chronology of the study ................................................................................................................ 25 
Table 9. Budget summary by line item category ......................................................................................... 25 
 
 
 

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Abstract 
Background 
Acute malnutrition is the most life-threatening form of undernutrition. Moderate and severe acute 
malnutrition (MAM, SAM) are effectively treated with ready-to-use therapeutic foods (RUTFs) but there is 
a need to lower the cost of treatment and improve treatment regimens to reduce risk of relapse 
MAM/SAM episodes following recovery. The currently used standard formulation of RUTF contains 
peanuts and dairy, which pose problems due to their high cost, the need to import ingredients to the 
Global South (in the case of dairy), and risk of aflatoxin (in the case of peanuts). Before alternative 
formulations of RUTF can be recommended, however, there is the need for data on the efficacy of these 
formulations on recovery rates and to what extent recovery is sustainable. Sustainable recovery implies a 
lower rate of post-treatment relapse. 
 
Objectives 
Our objectives are as follows: (1) To assess the non-inferiority of novel soy-maize-sorghum (SMS-) RUTF 
and soy-based (S-) RUTF on treatment recovery to standard RUTF; (2) To assess the superiority of SMS-
RUTF and S- RUTF on post-recovery relapse compared to standard RUTF; (3) To assess the costs of a 
treatment course of SMS-RUTF, S-RUTF, and standard RUTF; (4) To assess the effect of SMS-RUTF and S-
RUTF on microbiome composition and intestinal inflammation 
 
Methodology 
We will conduct a facility-based, individually randomized controlled trial with three arms allocated in a 
1:1:1 allocation ratio in 30 health facilities (Centre de Santé et Promotion Sociale [CSPS]) in Burkina Faso. 
We will randomize 1080 children with MAM and 1080 children with uncomplicated SAM 6-59 months of 
age to receive treatment with one of the following RUTFs: (1) standard of care, milk- and peanut-based 
RUTF (control group); (2) SMS-RUTF free of milk and peanuts and high in fiber (intervention 1); or (3) S-
RUTF free of milk and peanuts (intervention 2). Children will be enrolled upon presentation to facilities for 
MAM or uncomplicated SAM treatment. Follow up visits will be weekly during treatment for SAM children 
and bi-weekly during treatment for MAM children, and monthly for 3 months following discharge from 
treatment. The primary study outcomes are anthropometric recovery at discharge (a non-inferiority 
analysis) and relapse to MAM or SAM within the 3 months following recovery (a superiority analysis). We 
will employ an activity-based micro-costing approach to collect cost data on the direct and indirect medical 
costs, opportunity costs to caregivers, personnel, and overheads associated with outpatient MAM or SAM 
treatment. Fecal samples will be collected from children at a subset of facilities (5 facilities, ~60 children 
per treatment arm), at enrollment (initiation of treatment), discharge from treatment, and 3-months post-
discharge. Enrollment is planned to begin in October 2024, and follow up is planned to be completed in 
August 2025. Final results are planned to be available in December 2025. 
 
 

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Introduction 
Globally, 45 million children under the age of five suffer from wasting, a form of acute malnutrition 
characterized by extreme loss of muscle and fat tissue (1). Acute malnutrition dramatically increases the 
risk of death; compared to well-nourished children, children with moderate acute malnutrition (MAM) are 
3.4 times more likely to die, and this probability increases to a staggering 11.6 times in children with severe 
acute malnutrition (SAM) (2). Child acute malnutrition is the underlying cause for an estimated annual 
875,000 deaths of children under 5 years of age, representing about 12.6% of all deaths in this age group 
worldwide (3).  
More than a decade ago, the World Health Organization (WHO) endorsed the community-based 
management of acute malnutrition (CMAM) model to address severe acute malnutrition. The specific aim 
was to tackle the low coverage and high case-fatality of the existing inpatient treatment model (4). CMAM 
entails the active case-finding and referral of children with severe acute malnutrition by community health 
workers or volunteers to first-line health services and the outpatient treatment of children with severe 
acute malnutrition who demonstrate sufficient appetite and have no medical complications (5). A key 
development that facilitated the shift to the outpatient model was the introduction of energy-dense 
ready-to-use therapeutic foods (RUTF). RUTF provides a convenient and safe way to deliver the energy 
and nutrients needed for children suffering from severe acute malnutrition to recover. The supplements 
can be consumed directly from the package, do not require cold-chain, and are microbiologically safe (6).  
Current World Health Organization guidelines stipulate that at least half of the proteins in the RUTF should 
come from milk products (5,7). The milk content, however, constitutes 25% of the total product cost and 
makes RUTF very expensive for use in resource-constrained settings. In addition, it reduces the products 
environmental sustainability and increases the need to import ingredients into these settings (8). New 
RUTF formulations that replace the milk protein (the most expensive ingredient) with cheaper sources of 
quality protein such as soy, maize, and sorghum have been developed. UNICEF has also noted the 
importance of developing non-peanut based RUTFs in regions where peanuts (which constitute 15% of 
total product costs) are not a staple food to improve local acceptance as well as to further reduce cost 
(7,9). Additionally, removing peanut ingredients would eliminate the risk of aflatoxin exposure. Replacing 
milk and peanut protein by other, plant-based proteins in RUTF reduces product cost, reduces the 
supplement’s carbon footprint, and, when the alternative ingredients are locally available, may increase 
adoption by local governments and acceptance by local communities. Reducing the cost of RUTF can thus 
contribute significantly to improving the affordability of and access to the treatment for SAM, thus 
increasing treatment coverage. 
Before scaling-up the use of new and more affordable RUTF formulations, rigorous evidence on their 
efficacy and cost-efficacy is needed. The proposed project seeks to generate this evidence for two 
alternative RUTF formulations that are free of milk and peanut. Furthermore, one of the formulations has 
a significantly higher fiber content compared to the currently used milk-based RUTF (5.0g vs. 0.75g per 
100g). A recent pilot study in Bangladesh found that a milk-free and fiber-rich ready-to-use formula had 
superior outcomes in weight gain and recovery from acute malnutrition associated with a change in 
microbiota components linked to child growth (16). The study also reported significantly lower relapse 
rates than the standard formulation. However, a Cochrane review of RUTF treatment reported relapse 
rates were higher in children receiving an alternative RUTF (many of which contained lower milk powder 

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than the comparator, or no milk powder) (10). Additional studies are warranted to confirm the prebiotic 
effect of fiber-rich formulas on weight gain and gut health, and the prevention of post-treatment relapse. 
This study will test the efficacy of peanut-free and milk-free RUTF formulations for the treatment of acute 
malnutrition in young children. The study responds to a UNICEF call for more research that supports 
inclusion of novel plant-based RUTF products in their portfolio and create more opportunities for local 
production of RUTF. As a consequence, the results will have an immediate impact on UNICEF’s and 
countries’ RUTF strategy and are expected to contribute to reducing the cost of treating children with 
acute malnutrition. 
Research objectives 
Our primary research objectives are as follows: 
1. To assess the non-inferiority of novel Soy-Maize-Sorghum (SMS-) RUTF and Soy-based (S-) RUTF 
on treatment recovery to standard RUTF 
2. To assess the superiority of SMS-RUTF and S- RUTF on post-recovery relapse compared to standard 
RUTF 
 
Our secondary research objectives are as follows: 
1. To assess the costs of a treatment course of SMS-RUTF, S-RUTF, and standard RUTF 
2. To assess the effect of SMS-RUTF and S-RUTF on intestinal permeability/inflammation and 
microbiome composition including enteropathogen burden 
3. To assess the acceptability of SMS-RUTF and S-RUTF  
4. To assess the non-inferiority of SMS-RUTF and S-RUTF on length of stay in treatment among 
recovered children 
5. To assess the non-inferiority of SMS-RUTF and S-RUTF on weight gain during treatment 
6. To assess the non-inferiority of SMS-RUTF and S-RUTF on default from treatment 
7. To assess the non-inferiority of SMS-RUTF and S-RUTF on transfers to inpatient treatment 
8. To assess the non-inferiority of SMS-RUTF and S-RUTF on non-response to treatment 
9. To assess the non-inferiority of SMS-RUTF and S-RUTF on adherence to treatment services 
10. To assess the non-inferiority of SMS-RUTF and S-RUTF on compliance to treatment services 
11. To assess the non-inferiority of SMS-RUTF and S-RUTF on anthropometry at discharge from 
treatment 
12. To assess the superiority of SMS-RUTF and S-RUTF on anthropometry at 3-months post-discharge 
13. To assess the superiority of SMS-RUTF and S-RUTF on relapse to SAM post-discharge among 
recovered children 
14. To assess the superiority of SMS-RUTF and S-RUTF on relapse to MAM post-discharge among 
recovered children 
15. To assess the non-inferiority of SMS-RUTF and S-RUTF on hemoglobin at discharge and superiority 
of SMS-RUTF and S-RUTF on hemoglobin at 3-months post-discharge 
16. To assess the non-inferiority of SMS-RUTF and S-RUTF on anemia at discharge and superiority of 
SMS-RUTF and S-RUTF on anemia at 3-months post-discharge 
 

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Methodology 
Study setting and site selection 
Burkina Faso is a land-locked country in West Africa with a high burden of wasting, with national 
prevalences estimated at 9.7% of children under age 5 (11). Burkina Faso has seen deteriorating 
humanitarian conditions since 2020, with numbers of internally displaced persons (IDPs) exceeding 2 
million due to security incidences, and increasing populations refugees primarily from Mali. In addition to 
the intensifying displacement, the food security situation has deteriorated significantly and 630,000 
children in Burkina Faso are projected to be acutely malnourished in 2023. This study will be conducted in 
30 health centers (Centres de Santé et Promotion Sociale [CSPSs]) in the Hauts-Basin region of Burkina 
Faso. CSPSs with the highest caseloads in the Dande, Dafra, Karangasso, and Hounde health districts will 
be selected.  
Study design 
This will be a facility-based, individually randomized, controlled trial with three arms, including two 
interventions (SMS-RUTF and S-RUTF) and one control arm (standard RUTF), and a 1:1:1 allocation ratio. 
Children will be enrolled upon initiation of MAM or SAM treatment and followed for 3 months post-
discharge from treatment. The national CMAM protocol of Burkina Faso will be followed when evaluating 
the different RUTFs. 
 
Randomization procedure 
A statistician who is not part of the research team will generate a randomization scheme for the allocation 
of the 3 supplements. Each unique randomization number is randomly allocated to 1 of 9 letter codes 
(e.g., A, E, I, Z, K, T, N, E, S)—3 letters for the SMS-RUTF supplement, 3 letters for the S-RUTF supplement 
and 3 letters for the standard RUTF (control group)—using a computer program in permuted blocks of 15. 
Without notifying the investigators, the statistician will inform the producers which letters to print on the 
package of each supplement. Information regarding the assignment of the letter codes to the intervention 
and control supplements is sealed in opaque envelopes, who locked the envelope away until analysis was 
completed. Before the study started, the clinical research coordinator will seal each of the randomization 
numbers with the corresponding letter codes of the RUTF supplements into separate opaque envelopes 
that were marked with unique participant numbers to be attributed at study inclusion. At study inclusion, 
the study nurse opens the next sealed envelope in the presence of an eligible mother-child pair (in order 
of arrival) and provides them with the RUTF supplement according to the letter code. The participant’s 
number, as well as the letter code, will be written down on the study participant’s card. 
 
Study participants and determination of eligibility 
The population for this study will be children 6-59 months old with MAM or uncomplicated SAM 
presenting to the study facilities. MAM will be defined as middle upper arm circumference (MUAC) ≥ 11.5 
and < 12.5 cm, or weight-for-length/height z-score (WLZ/WHZ) ≥-3 and < -2. Uncomplicated SAM (i.e., 
cases of SAM that are eligible for outpatient treatment) will be defined by all the following criteria: (i) 
MUAC < 11.5 cm or WLZ/WHZ < -3, (ii) no clinical complications, and (iii) child passes the appetite test (the 
child eats at least the amount of RUTF required for passing the appetite test as per Burkina Faso national 
guidelines (12)).  

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The inclusion criteria are therefore: 
• 
Age 6-59 months 
• 
MUAC < 12.5 cm, or WLZ/WHZ < -2 
• 
Absence of clinical complications 
• 
Pass the appetite test 
• 
Accompanied by caregiver or legal guardian 
• 
Caregiver or legal guardian consents to participate 
 
Children will be excluded if they meet any of the following criteria: 
• 
Acute malnutrition requiring hospitalization (presence of clinical complications, failure to pass the 
appetite test, or presence of bilateral pitting edema (12)) 
• 
Known allergy to any of the ingredients in the RUTF products 
• 
Already enrolled in MAM or SAM treatment program 
• 
Presence of physical abnormalities that make measurement of anthropometry impossible 
• 
Caregiver has intention to move out of the study area within the next 6 months 
• 
Children referred from in-patient facilities to continue in ambulatory care 
 
Children will be screened for eligibility upon presentation at the study health centers, and will be 
determined to be eligible upon diagnosis with MAM or uncomplicated SAM. Because treatment coverage 
is low in Burkina Faso, the project will organize mass screening campaigns in surrounding villages to detect 
and refer all MAM and SAM cases for treatment. Additionally, the project will strengthen wasting screening 
at consultations and well-baby vaccination visits at the study health centers to increase coverage of 
screening and referrals to treatment. 
 
Informed consent 
The caregivers or legal guardian of eligible children will undergo the informed consent process. The 
Information Sheet and Informed Consent form will be read to the caregiver/ legal guardian of the eligible 
child in their language. The caregiver/ legal guardian will be given opportunities to ask any questions, and 
his/her comprehension of the form will be confirmed. He/she will sign the consent form if he/she agrees 
to participate. If the caregiver/ legal guardian is illiterate, a thumbprint will be collected to substitute for 
a signature.  
 
Study intervention and control arms 
Children admitted into MAM or SAM treatment at the study centers will be randomized to one of three 
RUTF formulations: 
• 
Standard of care RUTF (control): composed of milk powder, sugar, vegetable oil, peanut butter, 
vitamins, and minerals and low in fiber (0.75g per 100g) 
• 
Alternative, soy-maize-sorghum-RUTF (SMS-RUTF) formulation (intervention 1): a milk- and 
peanut-free product with added crystalline amino acids that provide significantly more fiber (5.0g 
per 100g)  

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• 
Alternative, soy-based RUTF (S-RUTF) formulation (intervention 2): a milk- and peanut-free 
product with added crystalline amino acids 
 
Burkina Faso national guidelines for MAM and SAM treatment will be followed for dosing the products and 
all other aspects of treatment (Table 1 and  
Table 2). Thus, all children will receive the standard of care for CMAM treatment in Burkina Faso, with the 
only difference between treatment arms being the product received. Burkina Faso national guidelines for 
CMAM are detailed in the guideline document (12). Briefly, upon admission to treatment for SAM, children 
will undergo medical evaluation and receive routine antibiotics and rapid diagnostic test for malaria as well 
as other treatment as indicated in the guidelines. The caregiver of the child will be provided with RUTF 
and instructed on how to use to use it. Children will be followed weekly at the health center to be re-
evaluated. At the follow-up visits, children’s anthropometry will be measured, a clinical examination will 
be performed, and the caregiver will be provided with another 7-days’ supply of RUTF with instructions. 
Children will be treated a maximum of 12 weeks and will be eligible to be discharged when they have 
achieved anthropometric recovery (defined in Table 3). For MAM, upon admission to treatment, children 
will be provided with RUTF to be used as a food supplement in addition to the child’s usual diet. Caregivers 
will be provided with the product and instructed on its use, and receive nutritional counseling as per 
guidelines. Children will receive medical treatments as indicated in the guidelines, and instructed to return 
to the health facility every two weeks for monitoring. Children will be treated for a maximum of 12 weeks 
and be eligible for discharge when they have achieved anthropometric recovery.  
Table 1. Burkina Faso guidelines for dosage for MAM (12) 
Sachets per day 
(92 gram 
sachets)  
Sachets per week 
(92 gram 
sachets) 
Sachets per two 
weeks (92 gram 
sachets) 
1 
7 
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Table 2. Burkina Faso guidelines for dosage for SAM (12) 
 
 
 
 
 
 
 
Storage of product 
Child’s 
weight 
(kilograms) 
RUTF - grams 
RUTF – sachets (92 grams) 
Grams per day  Grames per week  Sachets per day 
Sachets per week 
3.0-3.4  
105  
750  
1 ¼  
8  
3.5 – 4.9  
130  
900  
1 ½  
10  
5.0 – 6.9  
200  
1400  
2  
15  
7.0 – 9.9  
260  
1800  
3  
20  
10.0 – 14.9  
400  
2800  
4  
30  
15.0 – 19.9  
450  
3200  
5  
35  
20.0 – 29.9*  
500  
3500  
6  
40  

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All products will be stored according to instructions from the manufacturer, in a dry and cool place at a 
temperature below 30° C out of direct sunlight. Prior to providing participants with products, the products 
will be inspected visually for damage. Quality control procedures will be detailed in a study standard 
operating procedure (SOP). 
Outcomes 
The outcomes of the study, their definitions, and type of analysis (non-inferiority or superiority) are listed 
in Table 3. Treatment outcomes will be evaluated through non-inferiority, and post-treatment outcomes 
will be evaluated through superiority analyses. This is because the intervention products may have the 
important benefits described above of being lower cost than the standard RUTF, increased potential to be 
produced locally, and free of aflatoxin, but evidence is needed to confirm they are acceptably similar in 
treatment outcomes. The composition of these alternative formulations may also improve gut health, 
possibly reducing the risk of relapse. Thus, post-discharge relapse outcomes are analyzed in superiority 
analyses. 
 
Table 3. Primary and secondary study outcomes 
Outcomes 
Definition 
Type of analysis 
Primary outcomes 
Anthropometric 
recovery at 
discharge 
WLZ ≥ -2 and MUAC ≥ 125 mm and absence of bilateral 
pitting edema for two consecutive visits 
Non-inferiority 
Relapse to wasting 
within 3-months 
post-discharge 
A new episode of wasting (defined as WLZ/WHZ < -2 or 
MUAC < 125 mm or presence of bilateral pitting edema) 
within the 3-month period following recovery from the 
index wasting episode, among children who recovered 
from their index episode 
Superiority 
Secondary outcomes 
Length of stay (LOS) 
among recovered 
children: 
The number of days between the day the child is 
admitted to treatment and the day the child is 
determined to be recovered and thus discharged from 
treatment 
Non-inferiority 
Weight gain 
Change in child’s weight (gram/kilogram/day) between 
weight on day of admission to treatment and day of 
discharge 
Non-inferiority 
Default from 
treatment 
Child is absent for two consecutive visits, declared a 
defaulter on the second visit 
Non-inferiority 
Transfer to inpatient 
treatment 
Referral or admission to hospital for inpatient treatment 
during the treatment course 
Non-inferiority 
Non-response to 
treatment 
Any of the following criteria are met: Absence of weight 
gain after 5 weeks or at the third visit; weight loss for 
more than 4 weeks in the program or at the second visit; 
loss of more than 5% of body weight compared to 
admission weight at any time; or anthropometric 
recovery criteria not met after 3 months of follow-up in 
CMAM 
Non-inferiority 

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Adherence to 
treatment services 
Caregiver attends the recommended schedule of visits 
and receive RUTF supply 
Non-inferiority 
Compliance to 
treatment services 
The child receives the recommended dose of the RUTF 
each day 
Non-inferiority 
Anthropometry at 
discharge from 
treatment 
WLZ/WHZ, MUAC, weight, height/length, LAZ/HAZ and 
WAZ at discharge from treatment 
Non-inferiority 
Anthropometry at 3-
months post-
discharge 
WLZ/WHZ, MUAC, weight, height/length, LAZ/HAZ and 
WAZ at 3-months post-discharge 
Superiority 
Relapse to SAM 
A new episode of SAM (WLZ/WHZ < -3 or MUAC < 115 
mm or presence of bilateral pitting edema) within the 3-
month period following recovery from the index wasting 
episode 
Superiority 
Relapse to MAM 
A new episode of MAM (WLZ/WHZ <-2 and ≥-3, or MUAC 
<125 mm and ≥115 mm) within the 3-month period 
following recovery from the index wasting episode 
Superiority 
Morbidity 
Indication of morbidity (acute respiratory infections, 
diarrhea, fever, or malaria) on health center card 
Non-inferiority 
Hemoglobin at 
discharge 
Hemoglobin concentration (grams/liter) at discharge  
Non-inferiority 
Hemoglobin at 3-
months post-
discharge 
Hemoglobin concentration (grams/liter) at 3-months 
post-discharge 
Superiority 
Anemia at discharge 
For 
children 
6-23 
months 
of 
age: 
Hemoglobin 
concentration < 105 gram/liter at discharge 
For children 24-59 months of age: Hemoglobin 
concentration < 110 gram/liter at discharge  
Non-inferiority 
Anemia at 3-months 
post-discharge 
For 
children 
6-23 
months 
of 
age: 
Hemoglobin 
concentration < 105 gram/liter at discharge 
For children 24-59 months of age: Hemoglobin 
concentration < 110 gram/liter at discharge  
Superiority 

14 
 
 
Sample size 
We estimate a total sample size of 1080 children with SAM (360 per arm) and 1080 children with MAM (360 per arm) will provide at least 90% 
statistical power to demonstrate non-inferiority for each comparison, with a non-inferiority margin of 10 percentage points, assuming a recovery 
rate in the control of 77% (Table 4). For relapse outcomes, sample size will be smaller, and thus power will be lower, because only recovered children 
will be included in the analysis. All calculations assume a one-sided α = 0.05 for non-inferiority and two-sided α = 0.05 for superiority analyses. 
 
Table 4. Sample size calculations 
Scenarios with at least 80% power are bolded. 
Primary 
outcome 
Analysis 
type 
Sample size 
per arm 
Outcome prevalences reported in 
literature 
Non-inferiority 
margin or 
detectable 
effect size 
Assumption on control 
group outcome 
prevalence/means in 
sample size calculations 
Power per 
comparison 
Anthropometric 
recovery at 
discharge 
Non-
inferiority 
360 MAM 
and 360 SAM 
children/arm 
enrolled; 306 
MAM and 
306 SAM 
children in 
analysis after 
15% attrition 
MAM recovery (with RUSF*): 73% 
(13); 73% (14); 85% (15) 
SAM recovery: 55.4% (16); 82.3% 
(17); 76% (18); 71% (pooled 
estimate from meta-analysis) (19) 
10 percentage 
points (absolute 
difference) 
55.4% (vs 45.4%) 
85.6% 
77.0% (vs 67.0%) 
90.0% 
82.3% (vs 72.3%) 
96.8% 
Relapse to 
wasting within 
3-months post-
discharge 
Superiority 
236 
children/arm 
in analysis 
(assuming 
77% of the 
306 children 
recover) 
Post-MAM relapse: 30% within 3 
months (period prevalence) (20); 
33% within 12-months (21) 
Post-SAM relapse: 6.8% 3-month 
cumulative incidence (22); 24% 2-
month cumulative incidence (23); 
30% within 3-months 
(unpublished); 2.6 episodes per 
child-year (unpublished); 1.3 
35% relative 
reduction 
(incidence rate 
ratio = 0.65) 
Incidence of 2.6 
episodes per child-year 
80.0% 
Prevalence of 30% (vs 
20%) 
71.0% 

15 
 
episodes per child-year 
(unpublished) 
*RUSF = ready-to-use supplementary food 
 

16 
 
Study procedures 
All staff will be trained in the study procedures, in order to screen for eligibility, determine eligibility, 
collect informed consent, administer study products, and conduct follow up procedures in accordance 
with the trial protocol and SOPs. Before enrollment of the first participant, all study procedures will be 
piloted for 2 weeks at the study sites to check for any procedural problems, collect feedback from facility 
staff and communities, and implement any revisions to procedures as needed. 
 
After informed consent is obtained, a unique participant number will be assigned to the participant. 
Clinical information related to the child’s wasting episode, including documentation of routine medications 
received, child’s anthropometry, and clinical status. In addition, the child’s medical history and clinical 
presentation details will be abstracted from their medical records as documented by the study clinician, 
and copies of the medical records will be stored in the child’s study file.  
 
The study nurse will provide counseling on the specifics of wasting treatment as per Burkina Faso 
guidelines, including the schedule of visits, how to use the RUTF throughout the treatment course, and 
the duration of treatment. As per Burkina Faso guidelines, the caregiver will return regularly to the facility 
for follow-up care for their child (weekly for SAM; bi-weekly for MAM), during which they will receive 
clinical exam to assess morbidity, measurement of anthropometry, and receive another 7-day supply of 
RUTF. The nurse will answer any questions the caregivers might have. Adherence will be assessed at these 
follow up visits through caregiver report. 
 
When the child meets the criteria for discharge, children will be counseled to return to the facility for post-
discharge follow up monthly for 3 months. At these post-discharge follow-up visits, caregivers will be asked 
about any admissions to hospital for wasting in the previous month, and the child will be screened for 
wasting. More details on data collection are given in the following section and in Table 7. 
 
Anthropometric and clinical procedures 
Anthropometric measurements will be taken at treatment initiation and discharge, weekly during the 
treatment course for SAM children and bi-weekly for MAM children, and monthly during the post-
discharge follow-up. The child's weight will be taken using an electronic scale to the nearest 100g. The 
length will be measured with a measuring board to the nearest 1 mm. MUAC will be measured using a 
non-stretch tape with 0.1 cm accuracy. All measurements will be taken twice by the study nurses and the 
average calculated. Weight-for-age, weight-for-length/height, and length/height-for-age z-scores will be 
calculated using the WHO 2006 growth standards (24).  
 
All children will be tested for malaria upon admission as per national guidelines for wasting treatment (12) 
through rapid diagnostic test using capillary blood. Capillary blood will be collected from all children via 
finger prick to measure hemoglobin concentration, at baseline (initiation of treatment) and at discharge. 
 
Costing  
We will employ an activity-based costing-ingredients (ABC-I) approach to collect and analyze data on costs 
incurred in each treatment arm. A societal perspective will be used, which includes all financial and 

17 
 
economic costs regardless of who incurs them; i.e. health system, implementing partners, and patients 
(25,26). This will include costs and opportunity costs to caregivers. We will have two activities, which are 
the treatment of MAM and the outpatient treatment of SAM. For these activities, we will assess the cost 
categories listed in Table 5. 
 
Table 5. Cost categories and their descriptions for costing analyses 
Cost category 
Description 
Direct medical costs 
Costs of all equipment, procedures, and consumables (medications 
and nutrition commodities [RUTFs]) used in the outpatient 
treatment of SAM or MAM, beginning at admission and ending at 
discharge 
Indirect medical costs 
Costs to caregivers incurred due to receiving outpatient SAM 
treatment, including cost of transportation and any food or lodging 
costs 
Opportunity costs to caregivers 
The valuation of the time that caregivers spend on having their child 
treated for wasting, including time traveling to and spent at OTPs. 
Missed income will be calculated, and, for caregivers who do not 
have paid employment outside the home, opportunity costs will be 
calculated using 60% of national GDP (27,28) and estimated amount 
of time spent participating in the program. 
Personnel 
Salaries of health workers involved in the admission, follow up, and 
discharge of outpatient SAM children 
Overheads 
Costs of infrastructure, management, administration, and logistical 
support  
 
Data sources will include accounting records and interviews. We will collect accounting data from the study 
hospitals that cover the time period of interest, which will provide an exhaustive list of inputs and materials 
and support used in the program. We will conduct interviews with staff members and other key actors 
involved in the treatment of SAM, and the management and logistical support. A subset of caregivers will 
be interviewed about their direct, indirect, and opportunity costs for the admission visit as part of the 
baseline questionnaires, and will be asked about these costs for the follow-up visits and discharge visit at 
the discharge visit. 
 
Costing data from accounting records and interviews will be entered into Excel spreadsheets, which will 
be used for the analysis. Data be securely stored on password-protected computers and on secure servers.  
 
We will estimate total costs, and the cost-efficiency and cost-effectiveness of the intervention. Cost-
efficiency refers to the estimates of cost per programmatic output, allowing for the comparison of 
programs that produce the same output. Cost-effectiveness refers to cost per health outcome, allowing 
an assessment of value-for-money of a health intervention given its health impacts. All outcomes are 
defined in Table 6. 

18 
 
 
If the interventions are demonstrated to be superior for relapse, we will calculate the cost per DALY averted 
between each intervention arm and the control. To do this, we will construct a decision tree model to 
compare the costs and effects of treatment with the intervention RUTFs relative to standard RUTF. The 
health states that will contribute to DALYs are SAM and death. The effects of the intervention package will 
include effects on relapse. Disability weights will be sourced from the most recently published Global 
Burden of Disease disability weight estimates. We will not employ age-weighting and discounting (29). 
Both probability and deterministic sensitivity analyses will be conducted. If the interventions are 
demonstrated to be non-inferior for both recovery and relapse outcomes, we will calculate the difference 
in costs between each intervention arm and the control.  
 
All analyses will be conducted using TreeAge, Excel, and Stata software. 
 
Table 6. Costing outcomes and their definitions 
Outcome 
Category 
Definition 
Cost per MAM child 
admitted into treatment 
Cost-efficiency 
Total cost of MAM treatment divided by the 
number of MAM children admitted into 
treatment during that time period 
Cost per SAM child 
admitted into treatment 
Cost-efficiency 
Total cost of SAM treatment divided by the 
number of SAM children admitted into 
treatment during that time period 
Cost per treated MAM 
child recovered 
Cost-effectiveness 
Total cost of MAM treatment divided by the 
number of MAM children recovered during that 
period (the number admitted into treatment 
during that time period multiplied by recovery 
rates) 
Cost per treated SAM child 
recovered 
Cost-effectiveness 
Total cost of SAM treatment divided by the 
number of SAM children recovered during that 
period (the number admitted into treatment 
during that time period multiplied by recovery 
rates) 
Cost per DALY averted 
Cost-effectiveness 
Difference in the cost of treatment between 
intervention and control groups divided by 
difference in DALYs between intervention and 
control groups 
 
Acceptability sub-study 
We will conduct a rapid assessment of acceptability of each product in a convenience sample of 40 SAM 
and MAM children, after the study enrollment target has been reached. A total of two feeding sessions 
will be organized with a washout period of two hours in between sessions. The sample of caretaker-child 
dyads will be divided in strata by child age and subsequently randomly be allocated to one of 4 schedules 

19 
 
per age stratum: i) AB; ii) BA; iii) AC; iv) CA with A being the standard RUTF, B the SMS-RUTF and C the S-
RUTF. For each session, a single dose of 92 g of RUTF will be provided. Caretakers will be asked to feed 
their child ad libitum for 30 min. The feeding will be directly observed by data collectors. The remaining 
portion will be weighed, and the consumed quantity will be calculated by subtraction. Data collectors 
will observe the feeding experiment and collect qualitative data on caretakers’ and children’s behavior 
during the feeding experiment. A short post-exit interview with caretakers will collect the caretakers’ 
perceptions of the different RUTF products. 
 
Fecal sample analysis sub-study 
Children with SAM suffer from higher levels of gut inflammation, more immature gut microbiome profiles, 
and higher enteric pathogen burdens than their well-nourished counterparts (30–32). While standard 
RUTF is effective in aiding anthropometric recovery, this compromised gut health may not be addressed 
by standard formulations, as children with SAM can experience persistent microbiome maturity even after 
therapeutic feeding (33). Alternative formulas may hold promise for improving gut health, through 
pathways such as high fiber and/or short chain fatty acids content (31,34). A pilot study in Bangladesh 
reported a milk-free and fiber-rich ready-to-use food had superior outcomes in anthropometric outcomes 
among children with wasting, associated with a change in microbiota components linked to child growth 
(16). Thus we hypothesize that these new formulations may impact post-recovery outcomes by improving 
gut health. The objective of this sub-study is thus to assess if the alternative RUTFs have any impact on 
two specific sets of mechanistic outcomes (intestinal permeability/inflammation and microbiome profile 
including enteropathogen burden) that can support this theory of change of the intervention on the main 
study outcomes.  
A first hypothesis by which milk- and peanut-free RUTF can lead to higher rates of sustainable recovery is 
reducing intestinal permeability and inflammation as compared to standard RUTF. For this purpose, we 
propose to analyze three indicator molecules. α-1 antitrypsin is a marker for intestinal protein loss and can 
serve as an indicator for gastrointestinal disorders that affect gut integrity and intestinal permeability. Fecal 
neopterin and myeloperoxidase are markers for intestinal inflammation often associated with the 
presence of enteropathogens. All three molecules are analyzed using commercially available enzyme-
linked immunosorbent assays (ELISAs). A second hypothesis is that alternative RUTFs provide fewer 
substrates for enteropathogen growth and lead to improved gut microbiota abundance and age-
appropriate diversity. For this purpose, we will assess a set of common enteropathogens using a TaqMan 
Array Card1 assay specifically designed for pathogens associated with child growth. Fecal microbiota will 
 
1 Enteropathogen detection will be conducted using the TaqMan Array Card (TAC) system, a 384-well singleplex real-time PCR format used to 
detect 62 infection targets 62 including viruses, bacteria, protozoa and helminths, specifically: A. duodenale & lumbricoides; B. fragilis & 
hominis; C. belli, cayetanensis, coli, concisus, difficile, hominis, jejuni, parvum, troglodytis, & upsaliensis; E. bieneusi & histoly tica; G. 
lamblia; H. pylori; M. tuberculosis; N. americanus; P. shigelloides; S. enterica, flexneri, mansoni, sonnei, & stercoralis; T. solium & 
trichiura; V. cholerae; enteroaggregative E. coli [EAEC (aaiC, aatA, & aagR)], enteroinvasive E. coli [EIEC (Shingella spp.)], 
enteropathogenic E. coli [EPEC (bfp1 & eae)], enterotoxigenic E. coli [ETEC (LT, STh, & STp)], and Shiga toxin (stx1 & stx2) producing E. 
coli; Campylobacter pan. & Entamoeba pan.; Aeromonas spp., Cryptosporidium spp., Encephalitozoon spp., & Schistosoma spp.; 
adenovirus (serotypes 40 and 41), astrovirus, Epstein-Barr virus (EBV), norovirus (GI/GII & GI.1/GII.4), rotavirus, and sapovirus; 
antibiotic resistance genes, including: β-lactam (CTX-M, TEM, SHV), carbapenemases/carbapenems (KPC, NDM, MCR-1, OXA), macrolide 
(ermB, mphA), and quinolone (QnrA, QnrB1, QnrB4, QnrS).  
 

20 
 
be characterized using shotgun metagenomics to analyze bacterial DNA. Metagenomic data will be 
processed into abundance tables using R (R core team, 2021). Alpha and beta diversity parameters will 
then be computed and compared between treatment arms. A differential abundance analysis will be 
performed to identify bacterial taxa whose abundance is significantly altered by the milk- and peanut-free 
RUTF relative to the standard RUTF. 
Fecal samples will be collected for storage for these later analyses of the interventions’ effects on gut 
health biomarkers at a sub-set of 5 of the study health centers (approximately 60 children per study arm, 
to total 180 children with SAM).  
All SAM children at these 5 sites will be asked to a whole stool sample. For whole stool collection, the 
caregiver will be provided with a diaper and an adhesive urinary bag to prevent contamination by urine, 
and asked to wait until the child passes a stool, for a maximum of 4 hours after arrival. When the child 
passes a stool, the stool will be aliquoted into cryotubes and stored in a cooler bag immediately (within 
15 minutes of collection), before being transferred to storage with liquid nitrogen or long-term storage at 
-80° C within 2 hours of collection. Further details on stool collection procedures are documented in the 
annexed SOP (see Annex 3). 
Fecal samples will be collected at three timepoints: at baseline (initiation of treatment), at discharge from 
treatment, and at 3-months post-discharge. The baseline sample collection will occur before 
administration of antibiotics. 
 

21 
 
Table 7. Study procedures and data collection schedule 
 
Treatment course 
Post-treatment 
Wk 
0* 
Wk 
1 
Wk 
2  
Wk 
3 
Wk 
4 
Wk 
5 
Wk 
6 
Wk 
7 
Wk 
8 
Wk 
9 
Wk 
10 
Wk 
11 
Wk 
12** 
Wk 
13 
Wk 
14 
Wk 
15 
Wk 
16 
Wk 
17 
Wk 
18 
Wk 
19 
Wk 
20 
Wk 
21 
Wk 
22 
Wk 
23 
Wk 
24 
Determination 
of 
eligibility 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Informed consent 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical 
evaluation*** 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Costing caregiver 
questions (subset) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Anthropometry*** 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Monitoring of 
adverse events *** 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Capillary blood 
collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stool collection 
(subset) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*Initiation of wasting treatment 
**Discharge from wasting treatment (approximately week 12) 
***Follow up will be bi-weekly for MAM children and weekly for SAM children in accordance with national guidelines 
 
Data management and confidentiality 
Data will be collected by study staff at the study sites using standardized questionnaires and entered by study staff into electronic data capture 
system (Survey Solutions). Data will be regularly checked by designated staff for quality assurance. This electronic data capture system will be 
password-protected, secure, and only accessed by qualified study staff. Documents with identifiable information such as consent forms will be 
stored securely at the study office and accessed only by qualified study staff. All data collection will be directed by SOPs which will be developed 
and finalized prior to initiation of enrollment. 
 

22 
 
 
Statistical analysis 
All analyses will be delineated in detail in the trial Statistical Analysis Plan (SAP) which will be developed 
and finalized prior to initiation of enrollment. A summary is given here. 
 
The study is powered for separate comparisons between (i) the control group and SMS-RUTF, and (ii) 
between the control group and S-RUTF. All analyses will be stratified by MAM vs SAM status. 
 
Baseline characteristics will be assessed with descriptive statistics (means and standard deviations for 
continuous variables, and proportions for categorical variables). Baseline characteristics will be adjusted 
for in the analyses if it is both (i) associated with treatment outcomes or relapse in published literature 
and (ii) imbalanced between treatment arms as determined by statistically significant t-test or χ2 tests with 
5% significance level. 
 
For binary outcomes, we will use log-binomial regression to estimate relative risks (RRs) and 95% 
confidence intervals (CIs) for the RRs, adjusting for any baseline factors as appropriate. Non-inferiority will 
be declared if the lower bound of a one-sided 95% CI for the RR lies entirely below the non-inferiority 
margin of a relative 12.5%. For continuous outcomes, we will use linear regression to estimate differences 
in that outcome between treatment arms, adjusting for any baseline factors as appropriate. For superiority 
analyses (relapse), we will use a two-sided 95% CI and superiority will be declared if the lower bound of 
the 95% CI for the relative risk is above 1.0.  
 
Non-inferiority analyses can be spuriously favored by ITT analyses because non-compliance diminishes any 
treatment effects, thus biasing the effect size toward the null (35). We will therefore repeat all non-
inferiority analyses with a per-protocol (PP) population, restricting the analyses to only children who 
comply with their full treatment course, per caregiver report. The ITT and PP results will be presented 
side-by-side for non-inferiority analyses; superiority analyses will be analyzed as ITT only.  
 
Adverse event (AE) and serious adverse event (SAE) monitoring and reporting 
AEs and SAEs will be closely monitored and addressed in both study arms through the routine monitoring 
of children under wasting treatment, through weekly in-facility visits for SAM children and bi-weekly for 
MAM, as per national guidelines. AEs/SAEs will be documented in detail and reported to the study 
leadership. We will ensure the child receives appropriate medical care and monitoring as per guidelines. 
Definitions of AEs and SAEs are delineated in the annexed SOP (see Annex 4), where procedures are also 
documented in further detail. 
 
A Data Safety and Monitoring Committee (DSMC) will be formed prior to initiation of enrollment to 
monitor SAEs, to review the protocol, and evaluate the statistical analysis plan. The DSMC will consist of a 
professor in pediatrics with experience in child wasting, a professor in epidemiology, and a statistical 
analysis expert. Monthly AE/SAE summaries will be compiled and sent to the chair of the DSMC. In case 
of a disproportional rise in monthly SAEs, the chair will convene the DSMC to decide whether the trial 
should be halted. Given the short character of the trial, there will be no interim analysis. 

23 
 
 
Early withdrawal from the study 
While the study team intends to follow all participants from admission to treatment until 3 months post-
discharge from treatment, participants have the option to withdraw from the study at any time for any 
reason, in accordance with the principles of voluntary participation (outlined in more detail in the 
section on Ethics below). A participant may be withdrawn from the study by the principal investigator 
(who will be blinded to treatment allocation) if they believes it is in the participant's best interest to do 
so. The reason for early withdrawal will be documented in the participant's study file, and if the 
withdrawal is due to an SAE, prompt medical treatment will be ensured. 
 
Ethics  
The study protocol will be submitted for review to the Institutional Review Boards (IRBs) of IFPRI 
(Washington DC, USA), and the Burkina Faso National Ethics Committee. In accordance with IFPRI 
requirements, all IFPRI staff participating in the study will have completed the Collaborative Institutional 
Training Initiative (CITI Program) basic training "Social and Behavioral Research", which addresses 
research ethics issues in data collection, analysis, and management. The entire data collection team will 
be trained in, and bound by, the basic ethical principles as outlined in the Declaration of Helsinki (36). 
Community engagement 
The research team will inform local and regional health authorities and community representatives of the 
research. In each locality in the study area, representatives of the research team will present the 
objectives and procedures of the study to the village authorities.  
Voluntary and informed participation 
The purpose and procedures of the study will be explained to all caregivers of eligible children in their 
local language through an information sheet. All respondents reserve the right to refuse to participate in 
the study and to withdraw from the study at any time, for any reason. Each interviewer will be asked to 
read the consent statement in its entirety, slowly and in the participant's local language so that they can 
understand it. They will then ask if the consent statement has been understood and if there are any 
questions. Consent for children will be given by a parent or legal guardian. An informed consent form will 
be signed by the child's primary caregiver or legal guardian, and, if present, the heads of the household.  
Risks and benefits 
There are no known risks related to the data collection through questionnaires or anthropometry. The 
child may feel some pain with the finger prick for capillary blood collection, and there is a slight chance of 
bruising. There are no direct benefits to the participants for participating in the study. There is an indirect 
benefit to the participants by the generation of evidence that may serve to benefit the community. 

24 
 
AE/SAE response 
In the event of a medical problem (AE/SAE) that occurs or is identified during the assessment visits, all 
study participants will receive medical care. We will ensure that participants’ medical care expenses are 
covered, whether by the Burkina Faso health care system or by the study insurance. 
Participant privacy and confidentiality 
Every precaution will be taken to ensure the anonymity of participants during data collection, data 
management, data analysis and dissemination of results. Completed questionnaires will be stored on a 
secure server accessible only to the study team. All databases will be made anonymous using identification 
codes. No personally identifiable data will be shared outside the survey team or kept in the de-identified 
databases. 
Trial registration 
The trial will be registered with clinicaltrials.gov and any modifications to the study protocol or consent 
forms will be submitted for ethical approval before implementation.  
 
Record keeping and Trial Master File (TMF) management 
The TMF will be managed electronically by the investigator and investigator-sponsor team, in compliance 
with the ethical principles outlined above for participant privacy and confidentiality. The electronic TMF 
will be stored securely, will be password-protected, and will be accessed only by study staff. Prior to 
enrollment, the investigator and investigator-sponsor team will prepare and keep updated all 
documents. Written approval of the principal investigator will be obtained before destroying the TMF. 
The TMF will include, but not be limited to, the following documentation: 
• 
Approved protocol and any modifications, and all former versions 
• 
Current questionnaire forms 
• 
Insurance policy records 
• 
Signed and dated curriculum vitae of all investigators and study personnel 
• 
Approved informed consent forms in French and English, and all former versions 
• 
SAE reports 
• 
Investigators brochure and certificates of Good Manufacturing Practices for the interventional 
RUTF products 
• 
Signed SOPs 
• 
Budget details and financial aspects 
• 
Statistical Analysis Plan 
• 
Syntax for data quality checks 
• 
Staff delegation logs 
• 
Communication plan 
 

25 
 
Dissemination 
We will disseminate results from this research in peer-reviewed journals, at scientific conferences, and 
through stakeholder meetings to relevant study partners. 
Timeline summary 
The trial is slated to begin enrolling in October 2024, with final follow-up visits occurring in October 2025 
(Table 8). Primary analyses will be complete by February 2026. 
 
Table 8. Chronology of the study 
 
Y1 
Y2 
Y3 
Timeline 
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 
Protocol development and ethical review 
 
 
 
 
 
 
 
 
Production and shipment of RUTF  
 
 
 
 
 
 
 
 
Enrollment  
 
 
 
 
 
 
 
 
Recovery from SAM/MAM  
 
 
 
 
 
 
 
 
Post-recovery follow up 
 
 
 
 
 
 
 
 
Analysis of fecal samples 
 
 
 
 
 
 
 
 
  
Data analysis 
 
 
 
 
 
 
 
 
  
Manuscript writing 
 
 
 
 
 
 
 
 
  
 
Budget summary 
This study is funded by the Japan Ministry of Foreign Affairs and UNICEF supply division.  
 
Table 9. Budget summary by line item category 
Line item 
Amount 
 
Personnel 
 $573,815  
 
Training 
 $27,085  
 
Compensation for study participants 
 $45,627  
 
Insurance 
 $25,424  
 
Screening campaigns 
 $11,864  
 
Supplies including software and transport for supplies 
 $292,954  
 
Publication and dissemination 
 $7,100  
 
Meetings and sensitization 
 $3,220  
 
Travel and local transport for staff 
 $69,246  
 
Service charges 
 $123,752  
 
Institutional overheads 
 $275,947  
Total 
 $1,456,034  
 

26 
 
Roles of investigators 
 
Contact information 
Role  
Investigator 
IRSS 
01 BP 2779 Bobo-Dioulasso, 
Bobo-Dioulasso 
Burkina Faso 
Phone: +226 50 36 32 15 
- 
Laeticia Toe (Principal investigator): 
laeticiatoe@gmail.com  
- 
Trenton Dailey-Chwalibog: 
Trenton.Daileychwalibog@UGent.be 
 
- 
Principal investigator and 
co-investigator of this 
research 
- 
Guarantor of the research 
protocol 
- 
Oversight of study 
implementation 
- 
Quality control of data 
collection 
- 
Dissemination of results 
Implementing 
Agency 
AfricSante 
01 BP 298 Bobo-Dioulasso 01 
Street 15.144, 
Bobo-Dioulasso 01, Burkina Faso 
Phone: +226 20 98 63 68 
- 
Director Moctar Ouedraogo: bmoctar@gmail.com 
- 
Clinical research Coordinator: Dr Alain Hien: 
alain.hien1@gmail.com  
- 
Research implementation 
and data collection  
Investigator- 
Sponsor  
IFPRI  
1201 I St, NW, Washington, DC 20006-1002 USA  
Phone: +1 202-862-5600  
Fax: +1 202-467-4439  
Email:  
- 
Rebecca Brander: R.Brander@cgiar.org 
- 
Lieven Huybregts: L.Huybregts@cgiar.org 
- 
Jef Leroy: J.Leroy@cgiar.org 
IFPRI Dakar  
Title 3396, Lot #2  
BP 24063 Dakar Almadies Senegal  
Phone: +221 33 869 9800  
Email: 
- 
Talla Fall: T.Fall@cgiar.org  
- 
Co-investigator 
- 
Guarantor of the research 
protocol 
- 
Statistical analysis plan 
- 
Oversight of study 
implementation 
- 
Quality control of data 
collection 
- 
Dissemination of results 
Funding 
sponsors 
• The Ministry of foreign affairs of Japan, represented 
by Mr Futoshi Yamauchi F.Yamauchi@cgiar.org  
• UNICEF  
- 
Alison Fleet: afleet@unicef.org 
- 
Sondos Mubarak: smubarak@unicef.org  
Grantor 
 
 

27 
 
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