Clinical trial NCT06061484: Modified Dosage for Severe Acute Malnutrition
Official title: Safety Efficacy, and Cost-effectiveness of Modified Doses of Ready-to-use Therapeutic Food for the Treatment of Severe Acute Malnutrition Among Children 6-59 Months of Age in Ethiopia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Acute Malnutrition
Lead sponsor: Action Against Hunger USA
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Ethiopian Public Health Institute
First posted: 2023-09-29
Enrollment: 2400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: short-term nutritional recovery from severe acute malnutrition (SAM)
timeFrame: up to 16 weeks
Secondary outcomes:
measure: weight gain during treatment
timeFrame: weekly for up to 16 weeks
measure: MUAC gain during treatment
timeFrame: weekly for up to 16 weeks
measure: length/height gain during treatment
timeFrame: weekly for up to 16 weeks
measure: changes to phase angle (PhA) as measured by bioelectrical impedance analysis
timeFrame: up to weekly for up to 16 weeks
measure: changes to extracellular water (ECW) as measured by bioelectrical impedance analysis
timeFrame: up to weekly for up to 16 weeks
measure: changes to total body water (TBW) as measured by bioelectrical impedance analysis
timeFrame: up to weekly for up to 16 weeks
measure: changes to fat free mass as measured by bioelectrical impedance analysis
timeFrame: up to weekly for up to 16 weeks
measure: 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
timeFrame: up to weekly for up to 16 weeks
measure: rates of acute illness, including diarrhea, vomiting, and fever during treatment
timeFrame: weekly for up to 16 weeks
measure: mortality
timeFrame: up to 16 weeks
measure: hospitalization
timeFrame: up to 16 weeks
measure: duration of treatment required prior to short-term recovery
timeFrame: up to 16 weeks
measure: medium-term vital status
timeFrame: up to 6 months post-recovery
measure: medium-term nutritional status
timeFrame: up to 6 months post-recovery
measure: medium-term rates of relapse to SAM
timeFrame: up to 6 months post-recovery
measure: medium-term rates of relapse to MAM
timeFrame: up to 6 months post-recovery
measure: medium-term rates of hospitalization
timeFrame: up to 6 months post-recovery
measure: medium-term weight gain
timeFrame: up to 6 months post-recovery
measure: medium-term MUAC gain
timeFrame: up to 6 months post-recovery
measure: medium-term length/height gain
timeFrame: 6 months post-recovery
measure: medium-term phase angle (PhA) as measured by bioelectrical impedance analysis
timeFrame: 6 months post-recovery
measure: medium-term extracellular water (ECW) as measured by bioelectrical impedance analysis
timeFrame: 6 months post-recovery
measure: medium-term total body water (TBW) as measured by bioelectrical impedance analysis
timeFrame: 6 months post-recovery
measure: medium-term fat free mass as measured by bioelectrical impedance analysis
timeFrame: 6 months post-recovery
measure: 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
timeFrame: 6 months post-recovery
measure: short-term cost-efficiency
timeFrame: up to 16 weeks
measure: medium-term cost-efficiency
timeFrame: 6 months post-recovery
Other outcomes:
Locations:
city: Sekota
country: Ethiopia
facility: Sekota
state: Amhara
city: Teltele
country: Ethiopia
facility: Teltele
state: Oromia
city: Gode
country: Ethiopia
facility: Gode
state: Somali Region
Study officials:
affiliation: Action Against Hunger USA
name: Heather C Stobaugh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Indi Trehan, MD MPH DTM&H
role: PRINCIPAL_INVESTIGATOR
affiliation: Ethiopian Public Health Institute
name: Yosef B Asefaw, MSc
role: PRINCIPAL_INVESTIGATOR
References: