Moderate Acute MalnutritionMODAM-MAMNCT06056089
Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM)
A study testing ready-to-use supplementary food (RUSF) and ready-to-use therapeutic food (RUTF) in people with Moderate Acute Malnutrition, run by Action Against Hunger USA at 3 sites in Ethiopia.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Moderate Acute Malnutrition
- What is being tested?
- ready-to-use supplementary food (RUSF) and ready-to-use therapeutic food (RUTF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 3 sitesEthiopia
- Study dates
- 25 Sep 2023to 25 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Ethiopia3 sites, 3 recruiting
- Recruiting
Gode
Gode, Somali
Indi Trehan
- Not yet recruiting
Sekota
Sekota, Amhara
Indi Trehan
- Recruiting
Teltele
Teltelē, Oromiya
Indi Trehan
About this study
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
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.
- Conditions
- Moderate Acute Malnutrition
- Being tested
- ready-to-use supplementary food (RUSF), ready-to-use therapeutic food (RUTF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ready-to-use supplementary food (RUSF)Dietary supplement
standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/media/16636/file/S0000248-RUSF-Specification.pdf
ready-to-use therapeutic food (RUTF)Dietary supplement
standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 1 sachet (535 kcal) of RUSF per day Receives: Dietary Supplement: ready-to-use supplementary food (RUSF) |
| MAM Experimental A | Experimental | 1 sachet (500 kcal) of RUTF per day Receives: Dietary Supplement: ready-to-use therapeutic food (RUTF) |
| MAM Experimental B | Experimental | 2 sachets (1000 kcal) of RUTF per day Receives: Dietary Supplement: ready-to-use therapeutic food (RUTF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
short-term nutritional recovery from MAM
two consecutive weeks with MUAC > 12.4 cm and/or WHZ >= -2, depending on enrollment criteria
Measured: up to 16 weeks
Secondary outcomes (27)
weight gain during treatment
Measured: weekly for up to 16 weeks
mid-upper-arm circumference (MUAC) gain during treatment
Measured: weekly for up to 16 weeks
length/height gain during treatment
Measured: weekly for up to 16 weeks
changes to phase angle (PhA) as measured by bioelectrical impedance analysis
Measured: up to weekly for up to 16 weeks
changes to extracellular water (ECW) as measured by bioelectrical impedance analysis
Measured: up to weekly for up to 16 weeks
changes to total body water (TBW) as measured by bioelectrical impedance analysis
Measured: up to weekly for up to 16 weeks
changes to fat free mass as measured by bioelectrical impedance analysis
Measured: 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
Measured: up to weekly for up to 16 weeks
rates of acute illness, including diarrhea, vomiting, and fever during treatment
Measured: weekly for up to 16 weeks
mortality rate
Measured: weekly for up to 16 weeks
hospitalization rate
Measured: weekly for up to 16 weeks
duration of treatment required prior to short-term recovery
Measured: weekly for up to 16 weeks
medium-term mortality rate
calculated as number of children who die divided by total number of children initially enrolled
Measured: up to 6 months post-recovery
medium-term rate of development of acute malnutrition
calculated as number of children who develop acute malnutrition by the total number of children initially enrolled
Measured: up to 6 months post-recovery
medium-term rates of relapse to SAM
Measured: up to 6 months post-recovery
medium-term rates of relapse to MAM
Measured: up to 6 months post-recovery
medium-term rates of hospitalization
Measured: up to 6 months post-recovery
medium-term weight gain
Measured: 6 months post-recovery
medium-term MUAC gain
Measured: 6 months post-recovery
medium-term length/height gain
Measured: 6 months post-recovery
medium-term phase angle (PhA) as measured by bioelectrical impedance analysis
Measured: 6 months post-recovery
medium-term extracellular water (ECW) as measured by bioelectrical impedance analysis
Measured: 6 months post-recovery
medium-term total body water (TBW) as measured by bioelectrical impedance analysis
Measured: 6 months post-recovery
medium-term fat free mass as measured by bioelectrical impedance analysis
Measured: 6 months post-recovery
medium-term 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
Measured: 6 months post-recovery
short-term cost-efficiency
calculated as the total costs of the treatment for all children divided by the number of children who achieve nutritional recovery
Measured: up to 16 weeks
medium-term cost-efficiency
calculated as the total costs of the treatment for all children divided by the number of children who sustain nutritional recovery
Measured: 6 months post-recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start25 Sep 2023
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Moderate Acute MalnutritionStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Action Against Hunger USA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Ethiopian Public Health Institute
- Responsible party
- Principal investigator, Heather Stobaugh, Action Against Hunger USA
- Investigators
- Heather C Stobaugh, Principal investigator, Action Against Hunger USAIndi Trehan, Principal investigator, University of WashingtonYosef B Asefaw, MSc, Principal investigator, Ethiopian Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056089
- Sponsor's protocol ID
- MODAM-MAM
- Acronym
- MODAM-MAM
- Status last verified
- Jul 2024
- First submitted
- 8 Sep 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Clark BA, Legese LA, Beyene Y, Shellemew MW, Darsene H, Chitekwe S, Tessema M, Trehan I, Stobaugh HC. Comparative effectiveness of lipid-nutrient spread supplementation regimens for moderate acute malnutrition in Ethiopia: The MODAM-MAM individually randomized controlled trial. PLoS Med. 2026 Aug 11;23(8):e1005199. doi: 10.1371/journal.pmed.1005199. Online ahead of print.
PubMed 42579725Trehan 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.
PubMed 40200326
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06056089
- Acronym / sponsor ID
- MODAM-MAM / MODAM-MAM
- Conditions
- Moderate Acute Malnutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Action Against Hunger USAUniversity, hospital or other
- Collaborators
- University of Washington, Ethiopian Public Health Institute
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Dietary Supplement: ready-to-use supplementary food (RUSF)1 sachet (535 kcal) of RUSF per day |
| MAM Experimental A | Experimental | Dietary Supplement: ready-to-use therapeutic food (RUTF)1 sachet (500 kcal) of RUTF per day |
| MAM Experimental B | Experimental | Dietary Supplement: ready-to-use therapeutic food (RUTF)2 sachets (1000 kcal) of RUTF per day |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Control Group |
| 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 | Dietary supplement | MAM Experimental A, MAM Experimental B |
Primary outcome
short-term nutritional recovery from MAM
Time frame: up to 16 weeks
two consecutive weeks with MUAC > 12.4 cm and/or WHZ >= -2, depending on enrollment criteria
27 secondary outcomes
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
medium-term mortality rate
Time frame: up to 6 months post-recovery
medium-term rate of development of acute malnutrition
Time frame: up to 6 months post-recovery
medium-term rates of relapse to SAM
Time frame: up to 6 months post-recovery
medium-term rates of relapse to MAM
Time frame: up to 6 months post-recovery
medium-term rates of hospitalization
Time frame: up to 6 months post-recovery
medium-term weight gain
Time frame: 6 months post-recovery
medium-term MUAC gain
Time frame: 6 months post-recovery
medium-term length/height gain
Time frame: 6 months post-recovery
medium-term phase angle (PhA) as measured by bioelectrical impedance analysis
Time frame: 6 months post-recovery
medium-term extracellular water (ECW) as measured by bioelectrical impedance analysis
Time frame: 6 months post-recovery
medium-term total body water (TBW) as measured by bioelectrical impedance analysis
Time frame: 6 months post-recovery
medium-term fat free mass as measured by bioelectrical impedance analysis
Time frame: 6 months post-recovery
medium-term 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: 6 months post-recovery
short-term cost-efficiency
Time frame: up to 16 weeks
medium-term cost-efficiency
Time frame: 6 months post-recovery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Derived from this study: PubMed 42579725Clark BA, Legese LA, Beyene Y, Shellemew MW, Darsene H, Chitekwe S, Tessema M, Trehan I, Stobaugh HC. Comparative effectiveness of lipid-nutrient spread supplementation regimens for moderate acute malnutrition in Ethiopia: The MODAM-MAM individually randomized controlled trial. PLoS Med. 2026 Aug 11;23(8):e1005199. doi: 10.1371/journal.pmed.1005199. Online ahead of print.
- Derived from this study: PubMed 40200326Trehan 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.
- Individual participant dataSharing planned: Yes
Related trials for Moderate Acute Malnutrition
Enrolling by invitation
Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh
Moderate Acute Malnutrition (MAM), Undernutrition
Active, not recruiting
Regular Growth Monitoring (RGM) of Young Children in Guinea-Bissau
Severe Acute Malnutrition, Moderate Acute Malnutrition (MAM)
Not yet recruiting
Reduced Dosage and/or Visitation Protocol for the Treatment of Acute Malnutrition in Kenya
Acute Malnutrition in Childhood, Acute Malnutrition, Severe
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather C Stobaugh principal investigator
Action Against Hunger USA
Indi Trehan principal investigator
University of Washington
Yosef B Asefaw, MSc principal investigator
Ethiopian Public Health Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ready-to-use supplementary food (RUSF) and ready-to-use therapeutic food (RUTF) in people with Moderate Acute Malnutrition, run by Action Against Hunger USA at 3 sites in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Indi Trehan, MD MPH DTM&H (+12067696068, itrehan@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short-term nutritional recovery from MAM (time frame: up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06056089, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.