Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ready-to-use supplementary food (RUSF), ready-to-use therapeutic food (RUTF).
- Who it may be relevant to
- Registry conditions: Moderate Acute Malnutrition. Basic parameters: 6 months — 59 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ethiopia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety Efficacy, and Cost-effectiveness of Modified Doses of Ready-to-use Therapeutic and Supplementary Foods for the Treatment of Moderate Acute Malnutrition Among Children 6-59 Months of Age in Ethiopia
Overview
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 fixed-dose regimen of RUSF for children with MAM.
Interventions
- Dietary supplement ready-to-use supplementary food (RUSF)
standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/media/16636/file/S0000248-RUSF-Specification.pdf - Dietary supplement ready-to-use therapeutic food (RUTF)
standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf
Primary outcome measures
- short-term nutritional recovery from MAM [Time frame: up to 16 weeks]
Secondary outcome measures (12)
- weight gain during treatment [Time frame: weekly for up to 16 weeks]
- mid-upper-arm circumference (MUAC) gain during treatment [Time frame: weekly for up to 16 weeks]
- length/height gain during treatment [Time frame: weekly for up to 16 weeks]
- changes to phase angle (PhA) as measured by bioelectrical impedance analysis [Time frame: up to weekly for up to 16 weeks]
- changes to extracellular water (ECW) as measured by bioelectrical impedance analysis [Time frame: up to weekly for up to 16 weeks]
- changes to total body water (TBW) as measured by bioelectrical impedance analysis [Time frame: up to weekly for up to 16 weeks]
- changes to fat free mass as measured by bioelectrical impedance analysis [Time frame: up to weekly for up to 16 weeks]
- changes in immunological function during treatment as measured by quantification of T-cell recombination excision circles (TRECs) and kappa-deleting recombination excision circles (KRECs) on dried blood spots [Time frame: up to weekly for up to 16 weeks]
- rates of acute illness, including diarrhea, vomiting, and fever during treatment [Time frame: weekly for up to 16 weeks]
- mortality rate [Time frame: weekly for up to 16 weeks]
- hospitalization rate [Time frame: weekly for up to 16 weeks]
- duration of treatment required prior to short-term recovery [Time frame: weekly for up to 16 weeks]
Eligibility criteria
Inclusion criteria
- 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 moderate 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 of 115-124 mm without nutritional edema
- Weight-for-height Z-score (WHZ) between -2 and -3
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Ethiopia · 3 centers
- Sekota — Sekota
- Teltele — Teltelē
- Gode — Gode
Publications
- 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 40200326
Identifiers
NCT: NCT06056089 · MODAM-MAM