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| Name | Class |
|---|---|
| University of Washington | OTHER |
| Ethiopian Public Health Institute | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Standard weight-based dosing of Ready-to-Use Therapeutic Food (RUTF) at a dose of 150-200 kcal/kg/day |
|
| SAM Experimental A | Experimental | 2 sachets (1000 kcal) of RUTF per day |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Indi Trehan, MD MPH DTM&H | Contact | +12067696068 | itrehan@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sekota | Not yet recruiting | Sekota | Amhara | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40200326 | Derived | 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. |
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| ID | Term |
|---|---|
| D000067011 | Severe Acute Malnutrition |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Amoxicillin | Drug | Standard weight-based dosing per Ehtiopian national guidelines |
|
| 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 |
| changes to total body water (TBW) as measured by bioelectrical impedance analysis | up to weekly for up to 16 weeks |
| changes to fat free mass as measured by bioelectrical impedance analysis | 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 | up to weekly for up to 16 weeks |
| rates of acute illness, including diarrhea, vomiting, and fever during treatment | weekly for up to 16 weeks |
| mortality | up to 16 weeks |
| hospitalization | up to 16 weeks |
| duration of treatment required prior to short-term recovery | up to 16 weeks |
| medium-term vital status | calculated as number of children who die divided by total number of children initially enrolled | 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 | up to 6 months post-recovery |
| medium-term rates of relapse to SAM | up to 6 months post-recovery |
| medium-term rates of relapse to MAM | up to 6 months post-recovery |
| medium-term rates of hospitalization | up to 6 months post-recovery |
| medium-term weight gain | up to 6 months post-recovery |
| medium-term MUAC gain | up to 6 months post-recovery |
| medium-term length/height gain | 6 months post-recovery |
| medium-term phase angle (PhA) as measured by bioelectrical impedance analysis | 6 months post-recovery |
| medium-term extracellular water (ECW) as measured by bioelectrical impedance analysis | 6 months post-recovery |
| medium-term total body water (TBW) as measured by bioelectrical impedance analysis | 6 months post-recovery |
| medium-term fat free mass as measured by bioelectrical impedance analysis | 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 | 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 | 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 | 6 months post-recovery |
| Ethiopian Public Health Institute |
| Principal Investigator |
| Teltele | Recruiting | Teltelē | Oromiya | Ethiopia |
|
| Gode | Recruiting | Gode | Somali | Ethiopia |
|
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |