Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM)
- Conditions
- Moderate Acute Malnutrition
- Interventions
- Dietary Supplement: ready-to-use therapeutic food (RUTF)Dietary Supplement: ready-to-use supplementary food (RUSF)
- Registration Number
- NCT06056089
- Lead Sponsor
- Action Against Hunger USA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2400
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MAM Experimental A ready-to-use therapeutic food (RUTF) 1 sachet (500 kcal) of RUTF per day Control Group ready-to-use supplementary food (RUSF) 1 sachet (535 kcal) of RUSF per day MAM Experimental B ready-to-use therapeutic food (RUTF) 2 sachets (1000 kcal) of RUTF per day
- Primary Outcome Measures
Name Time Method 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
Name Time Method length/height gain during treatment 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 medium-term rates of relapse to SAM up to 6 months post-recovery medium-term length/height gain 6 months post-recovery medium-term extracellular water (ECW) as measured by bioelectrical impedance analysis 6 months post-recovery weight gain during treatment 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 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 MUAC gain 6 months post-recovery medium-term phase angle (PhA) 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
mid-upper-arm circumference (MUAC) gain during treatment weekly for up to 16 weeks mortality rate 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 total body water (TBW) 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 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 weight gain 6 months post-recovery medium-term total body water (TBW) as measured by bioelectrical impedance analysis 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
Trial Locations
- Locations (3)
Gode
🇪🇹Gode, Somali Region, Ethiopia
Sekota
🇪🇹Sekota, Amhara, Ethiopia
Teltele
🇪🇹Teltele, Oromia, Ethiopia