Modified Dosage for Severe Acute Malnutrition
MODAM-SAM
Safety Efficacy, and Cost-effectiveness of Modified Doses of Ready-to-use Therapeutic Food for the Treatment of Severe Acute Malnutrition Among Children 6-59 Months of Age in Ethiopia
1 other identifier
interventional
2,400
1 country
3
Brief Summary
Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. Two fixed-dose regimes of RUTF will be tested against the current weight-based dosing of RUTF for children with SAM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2023
CompletedStudy Start
First participant enrolled
September 25, 2023
CompletedFirst Posted
Study publicly available on registry
September 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 25, 2026
July 16, 2024
July 1, 2024
3 years
September 8, 2023
July 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
short-term nutritional recovery from severe acute malnutrition (SAM)
two consecutive weeks with MUAC \> 12.4 cm and/or WHZ \>= -2 and/or resolution of edema, depending on enrollment criteria
up to 16 weeks
Secondary Outcomes (27)
weight gain during treatment
weekly for up to 16 weeks
MUAC gain during treatment
weekly for up to 16 weeks
length/height gain during treatment
weekly for up to 16 weeks
changes to phase angle (PhA) as measured by bioelectrical impedance analysis
up to weekly for up to 16 weeks
changes to extracellular water (ECW) as measured by bioelectrical impedance analysis
up to weekly for up to 16 weeks
- +22 more secondary outcomes
Study Arms (3)
Control Group
ACTIVE COMPARATORStandard weight-based dosing of Ready-to-Use Therapeutic Food (RUTF) at a dose of 150-200 kcal/kg/day
SAM Experimental A
EXPERIMENTAL2 sachets (1000 kcal) of RUTF per day
SAM Experimental B
EXPERIMENTAL2 sachets (1000 kcal) per day while MUAC \< 115mm and/or edema and/or WHZ \< -3; then decreasing to 1 sachet (500 kcal) per day while MUAC 115-124 and WHZ -2 to -3 and no edema
Interventions
Standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf
Standard weight-based dosing per Ehtiopian national guidelines
Eligibility Criteria
You may qualify if:
- Age 6-59 months
- Reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year
- Uncomplicated severe acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility
- Pass appetite test conducted at the time of enrollment
- Consent for randomization into the study given by mother, father, and/or other primary caregiver
- Mid-upper arm circumference less than 115 mm and/or nutritional edema
- Weight-for-height Z-score (WHZ) less than -3
You may not qualify if:
- Complicated acute malnutrition with severe illness requiring transfer to a stabilization center or hospital for treatment. This includes, but is not limited to: a. Hypothermia b. High fever c. Signs of hypoglycemia d. Lethargy or altered mental status e. Moderate to severe dehydration f. Shock g. Other medical complications requiring hospitalization or higher-level medical evaluation
- Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months
- Known chronic medical illness such as severe cerebral palsy, severe congenital anomalies such as unrepaired congenital heart disease, Down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions that would be expected to contribute to difficulty feeding the prescribed amounts of therapeutic or supplementary food
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Action Against Hunger USAlead
- University of Washingtoncollaborator
- Ethiopian Public Health Institutecollaborator
Study Sites (3)
Sekota
Sekota, Amhara, Ethiopia
Teltele
Teltelē, Oromiya, Ethiopia
Gode
Gode, Somali, Ethiopia
Related Publications (1)
Trehan I, Beyene Y, Darsene H, Adams BS, Wrabel M, Gizaw G, Legese LA, Cichon B, Chitekwe S, Shellemew MW, Tessema M, Stobaugh HC. The Modified Dosages for Acute Malnutrition (MODAM) study: protocol for three integrated randomized controlled trials of novel approaches for the management of childhood wasting in Ethiopia. BMC Nutr. 2025 Apr 8;11(1):71. doi: 10.1186/s40795-025-01054-w.
PMID: 40200326DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather C Stobaugh, PhD
Action Against Hunger USA
- PRINCIPAL INVESTIGATOR
Indi Trehan, MD MPH DTM&H
University of Washington
- PRINCIPAL INVESTIGATOR
Yosef B Asefaw, MSc
Ethiopian Public Health Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Research and Learning Specialist
Study Record Dates
First Submitted
September 8, 2023
First Posted
September 29, 2023
Study Start
September 25, 2023
Primary Completion (Estimated)
September 25, 2026
Study Completion (Estimated)
September 25, 2026
Last Updated
July 16, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share