Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM)
Study Details
Study Description
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 RUTS for children with MAM.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Control Group 1 sachet (535 kcal) of RUSF per day |
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
Drug: Amoxicillin
Standard weight-based dosing per Ehtiopian national guidelines
|
| Experimental: MAM Experimental A 1 sachet (500 kcal) of RUTF per day |
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
Drug: Amoxicillin
Standard weight-based dosing per Ehtiopian national guidelines
|
| Experimental: MAM Experimental B 2 sachets (1000 kcal) of RUTF per day |
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
Drug: Amoxicillin
Standard weight-based dosing per Ehtiopian national guidelines
|
Outcome Measures
Primary Outcome Measures
- short-term nutritional recovery from MAM [up to 16 weeks]
two consecutive weeks with MUAC > 12.4 cm and/or WHZ >= -2, depending on enrollment criteria
Secondary Outcome Measures
- 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]
- 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 rate [weekly for up to 16 weeks]
- hospitalization rate [weekly for up to 16 weeks]
- duration of treatment required prior to short-term recovery [weekly for up to 16 weeks]
- medium-term mortality rate [up to 6 months post-recovery]
calculated as number of children who die divided by total number of children initially enrolled
- medium-term rate of development of acute malnutrition [up to 6 months post-recovery]
calculated as number of children who develop acute malnutrition by the total number of children initially enrolled
- 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 [6 months post-recovery]
- medium-term MUAC gain [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 [up to 16 weeks]
calculated as the total costs of the treatment for all children divided by the number of children who achieve nutritional recovery
- medium-term cost-efficiency [6 months post-recovery]
calculated as the total costs of the treatment for all children divided by the number of children who sustain nutritional recovery
Eligibility Criteria
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 (will not count towards planned sample size)
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:
- 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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Action Against Hunger USA
- University of Washington
- Ethiopian Public Health Institute
Investigators
- Principal Investigator: Heather C Stobaugh, Action Against Hunger USA
- Principal Investigator: Indi Trehan, University of Washington
- Principal Investigator: Yosef B Asefaw, MSc, Ethiopian Public Health Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MODAM-MAM