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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06056089
Other study ID # MODAM-MAM
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 25, 2023
Est. completion date September 25, 2026

Study information

Verified date September 2023
Source Action Against Hunger USA
Contact Indi Trehan, MD MPH DTM&H
Phone +12067696068
Email itrehan@uw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2400
Est. completion date September 25, 2026
Est. primary completion date September 25, 2026
Accepts healthy volunteers No
Gender All
Age group 6 Months to 59 Months
Eligibility 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 moderate 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 of 115-124 mm without nutritional edema 7. Weight-for-height Z-score (WHZ) between -2 and -3 (will not count towards planned sample size) 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Action Against Hunger USA Ethiopian Public Health Institute, University of Washington

Outcome

Type Measure Description Time frame Safety issue
Primary short-term nutritional recovery from MAM two consecutive weeks with MUAC > 12.4 cm and/or WHZ >= -2, depending on enrollment criteria up to 16 weeks
Secondary weight gain during treatment weekly for up to 16 weeks
Secondary mid-upper-arm circumference (MUAC) gain during treatment weekly for up to 16 weeks
Secondary length/height gain during treatment weekly for up to 16 weeks
Secondary changes to phase angle (PhA) as measured by bioelectrical impedance analysis up to weekly for up to 16 weeks
Secondary changes to extracellular water (ECW) as measured by bioelectrical impedance analysis up to weekly for up to 16 weeks
Secondary changes to total body water (TBW) as measured by bioelectrical impedance analysis up to weekly for up to 16 weeks
Secondary changes to fat free mass as measured by bioelectrical impedance analysis up to weekly for up to 16 weeks
Secondary 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
Secondary rates of acute illness, including diarrhea, vomiting, and fever during treatment weekly for up to 16 weeks
Secondary mortality rate weekly for up to 16 weeks
Secondary hospitalization rate weekly for up to 16 weeks
Secondary duration of treatment required prior to short-term recovery weekly for up to 16 weeks
Secondary medium-term mortality rate calculated as number of children who die divided by total number of children initially enrolled up to 6 months post-recovery
Secondary medium-term rate of development of acute malnutrition calculated as number of children who develop acute malnutrition by the total number of children initially enrolled up to 6 months post-recovery
Secondary medium-term rates of relapse to SAM up to 6 months post-recovery
Secondary medium-term rates of relapse to MAM up to 6 months post-recovery
Secondary medium-term rates of hospitalization up to 6 months post-recovery
Secondary medium-term weight gain 6 months post-recovery
Secondary medium-term MUAC gain 6 months post-recovery
Secondary medium-term length/height gain 6 months post-recovery
Secondary medium-term phase angle (PhA) as measured by bioelectrical impedance analysis 6 months post-recovery
Secondary medium-term extracellular water (ECW) as measured by bioelectrical impedance analysis 6 months post-recovery
Secondary medium-term total body water (TBW) as measured by bioelectrical impedance analysis 6 months post-recovery
Secondary medium-term fat free mass as measured by bioelectrical impedance analysis 6 months post-recovery
Secondary 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
Secondary 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
Secondary 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
See also
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Completed NCT01115647 - Treating Moderate Malnutrition in 6-24 Months Old Children N/A
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Completed NCT01898871 - Effectiveness of Nutritional Products to Treat Moderate Acute Malnutrition Phase 2
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Not yet recruiting NCT06305442 - Microbiota Directed Food for Children With Moderate Acute Malnutrition N/A
Terminated NCT03087097 - Transfer of Healthy Gut Flora for Restoration of Intestinal Microbiota Via Enema for Patients in the Rehabilitative Phase of Malnutrition Phase 1
Completed NCT03146897 - Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition N/A