Severe Acute MalnutritionMODAM-SAMNCT06061484

Modified Dosage for Severe Acute Malnutrition

A study testing ready-to-use therapeutic food (RUTF) and Amoxicillin in people with Severe Acute Malnutrition, run by Action Against Hunger USA at 3 sites in Ethiopia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 6 to 59 months
Conditions the study is for: Severe Acute Malnutrition
What is being tested?: ready-to-use therapeutic food (RUTF) and Amoxicillin
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 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

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.

Indi Trehan, MD MPH DTM&H contact

+12067696068

itrehan@uw.edu

Ethiopia3 sites, 3 recruiting

Gode
Gode, Somali
Indi Trehan
Recruiting
Sekota
Sekota, Amhara
Indi Trehan
Not yet recruiting
Teltele
Teltelē, Oromiya
Indi Trehan
Recruiting

Other trials in Ethiopia

About this study

Official title: 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

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.

Conditions: Severe Acute Malnutrition
Being tested: ready-to-use therapeutic food (RUTF), Amoxicillin
Medical subject headings: Severe Acute Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
AmoxicillinDrug
Standard weight-based dosing per Ehtiopian national guidelines

Study groups in NCT06061484
Study group	Role	What they receive
Control Group	Active comparator	Standard weight-based dosing of Ready-to-Use Therapeutic Food (RUTF) at a dose of 150-200 kcal/kg/day Receives: Dietary Supplement: ready-to-use therapeutic food (RUTF); Drug: Amoxicillin
SAM Experimental A	Experimental	2 sachets (1000 kcal) of RUTF per day Receives: Dietary Supplement: ready-to-use therapeutic food (RUTF); Drug: Amoxicillin
SAM Experimental B	Experimental	2 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 Receives: Dietary Supplement: ready-to-use therapeutic food (RUTF); Drug: Amoxicillin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: up to 16 weeks

Secondary outcomes (27)

weight gain during treatment
Measured: weekly for up to 16 weeks
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
Measured: up to 16 weeks
hospitalization
Measured: up to 16 weeks
duration of treatment required prior to short-term recovery
Measured: up to 16 weeks
medium-term vital status
calculated as number of children who die divided by total number of children initially enrolled
Measured: up to 6 months post-recovery
medium-term nutritional status
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: up to 6 months post-recovery
medium-term MUAC gain
Measured: up to 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.

25 Sep 202325 Sep 2026

First posted29 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 (1)Papers the sponsor has linked to this study.
Other trials for Severe 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06061484
Sponsor's protocol ID: MODAM-SAM
Acronym: MODAM-SAM
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

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.
PubMed 40200326

Want to know more?

Indi Trehan, MD MPH DTM&H

+12067696068

itrehan@uw.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Not yet recruiting
The Relapse to Acute Malnutrition Prevention (RAMP) Trial
Acute Malnutrition in Childhood, Acute Malnutrition, Severe
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
Recruiting
Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia
Acute Malnutrition, Severe, Malnutrition, Child
Active, not recruiting
Choline to Improve Malnutrition and Enhance Cognition
Severe Acute Malnutrition, Cognitive Impairment

All Severe Acute Malnutrition trials

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 Food for the Treatment of Severe Acute Malnutrition Among Children 6-59 Months of Age in Ethiopia
ClinicalTrials.gov ID: NCT06061484
Acronym / sponsor ID: MODAM-SAM / MODAM-SAM
Conditions: Severe 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: 29 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.

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 therapeutic food (RUTF), Drug: AmoxicillinStandard weight-based dosing of Ready-to-Use Therapeutic Food (RUTF) at a dose of 150-200 kcal/kg/day
SAM Experimental A	Experimental	Dietary Supplement: ready-to-use therapeutic food (RUTF), Drug: Amoxicillin2 sachets (1000 kcal) of RUTF per day
SAM Experimental B	Experimental	Dietary Supplement: ready-to-use therapeutic food (RUTF), Drug: Amoxicillin2 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

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 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

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 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	Control Group, SAM Experimental A, SAM Experimental B
AmoxicillinStandard weight-based dosing per Ehtiopian national guidelines	Drug	Control Group, SAM Experimental A, SAM Experimental B

Primary outcome

short-term nutritional recovery from severe acute malnutrition (SAM)
Time frame: up to 16 weeks
two consecutive weeks with MUAC > 12.4 cm and/or WHZ >= -2 and/or resolution of edema, depending on enrollment criteria

27 secondary outcomes

weight gain during treatment
Time frame: weekly for up to 16 weeks
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
Time frame: up to 16 weeks
hospitalization
Time frame: up to 16 weeks
duration of treatment required prior to short-term recovery
Time frame: up to 16 weeks
medium-term vital status
Time frame: up to 6 months post-recovery
medium-term nutritional status
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: up to 6 months post-recovery
medium-term MUAC gain
Time frame: up to 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 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 Severe Acute Malnutrition

Recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Not yet recruiting
The Relapse to Acute Malnutrition Prevention (RAMP) Trial
Acute Malnutrition in Childhood, Acute Malnutrition, Severe
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
Recruiting
Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia
Acute Malnutrition, Severe, Malnutrition, Child
Active, not recruiting
Choline to Improve Malnutrition and Enhance Cognition
Severe Acute Malnutrition, Cognitive Impairment

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.

Indi Trehan, MD MPH DTM&H contact

+12067696068

itrehan@uw.edu

Heather C Stobaugh, PhD principal investigator

Action Against Hunger USA

Indi Trehan, MD MPH DTM&H 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 therapeutic food (RUTF) and Amoxicillin in people with Severe 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 severe acute malnutrition (SAM) (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 NCT06061484, which also lists 1 linked publication.

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.