Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM)

NCT06056089 | Recruiting DMC

• 1 other identifier: MODAM-MAM
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 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 fixed-dose regimen of RUSF for children with MAM.

Conditions

Moderate Acute Malnutrition

Outcome Measures

Primary Outcomes (1)

• short-term nutritional recovery from MAM

  two consecutive weeks with MUAC \> 12.4 cm and/or WHZ \>= -2, depending on enrollment criteria

  up to 16 weeks

Secondary Outcomes (27)

• weight gain during treatment

  weekly for up to 16 weeks

• mid-upper-arm circumference (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

Study Arms (3)

Control Group

ACTIVE COMPARATOR

1 sachet (535 kcal) of RUSF per day

Dietary Supplement: ready-to-use supplementary food (RUSF)

MAM Experimental A

EXPERIMENTAL

1 sachet (500 kcal) of RUTF per day

Dietary Supplement: ready-to-use therapeutic food (RUTF)

MAM Experimental B

EXPERIMENTAL

2 sachets (1000 kcal) of RUTF per day

Dietary Supplement: ready-to-use therapeutic food (RUTF)

Interventions

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

Control Group

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

MAM Experimental A; MAM Experimental B

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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 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

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

Sponsors & Collaborators

• Action Against Hunger USA: lead
• University of Washington: collaborator
• Ethiopian Public Health Institute: collaborator

Study Sites (3)

Sekota

Sekota, Amhara, Ethiopia

NOT YET RECRUITING

Teltele

Teltelē, Oromiya, Ethiopia

RECRUITING

Gode

Gode, Somali, Ethiopia

RECRUITING

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: 40200326 DERIVED

Study Officials

• Heather C Stobaugh

  Action Against Hunger USA

  PRINCIPAL INVESTIGATOR

• Indi Trehan

  University of Washington

  PRINCIPAL INVESTIGATOR

• Yosef B Asefaw, MSc

  Ethiopian Public Health Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Indi Trehan, MD MPH DTM&H

CONTACT

+12067696068; itrehan@uw.edu

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 28, 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

Locations

ET (3)