Severe Acute Malnutrition
Conditions
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 weight-based dosing of RUTF for children with SAM.
Interventions
DIETARY_SUPPLEMENTready-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
DRUGAmoxicillin
Standard weight-based dosing per Ehtiopian national guidelines
Sponsors
Action Against Hunger USA
University of Washington
Ethiopian Public Health Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
1. Age 6-59 months 2. 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 3. Uncomplicated severe acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility 4. Pass appetite test conducted at the time of enrollment 5. Consent for randomization into the study given by mother, father, and/or other primary caregiver 6. Mid-upper arm circumference less than 115 mm and/or nutritional edema 7. Weight-for-height Z-score (WHZ) less than -3
Exclusion criteria
1. 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 2. Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| short-term nutritional recovery from severe acute malnutrition (SAM) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes to fat free mass as measured by bioelectrical impedance analysis | up to weekly for up to 16 weeks | — |
| 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 | 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 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 | up to 6 months post-recovery | calculated as number of children who die divided by total number of children initially enrolled |
| medium-term nutritional status | up to 6 months post-recovery | calculated as number of children who develop acute malnutrition by the total number of children initially enrolled |
| changes to total body water (TBW) as measured by bioelectrical impedance analysis | up to weekly for up to 16 weeks | — |
| 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 | 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 |
| medium-term rates of relapse to SAM | up to 6 months post-recovery | — |
Countries
Ethiopia
Contacts
Primary ContactIndi Trehan, MD MPH DTM&H
Outcome results
None listed