Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM)

Last updated: July 15, 2024
Sponsor: Action Against Hunger USA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Weight Loss

Diet And Nutrition

Treatment

Amoxicillin

ready-to-use therapeutic food (RUTF)

ready-to-use supplementary food (RUSF)

Clinical Study ID

NCT06056089
MODAM-MAM
  • Ages 6-59
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 6-59 months

  2. Reside in the catchment area of the health post where the trial is to be conductedwithout plans to leave the area over the next year

  3. Uncomplicated moderate acute malnutrition, as defined by no signs of severe illnessthat 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 otherprimary caregiver

  6. Mid-upper arm circumference of 115-124 mm without nutritional edema

  7. Weight-for-height Z-score (WHZ) between -2 and -3

Exclusion

Exclusion Criteria:

  1. Complicated acute malnutrition with severe illness requiring transfer to astabilization center or hospital for treatment. This includes, but is not limitedto: a. Hypothermia b. High fever c. Signs of hypoglycemia d. Lethargy or alteredmental status e. Moderate to severe dehydration f. Shock g. Other medicalcomplications requiring hospitalization or higher-level medical evaluation

  2. Treatment for acute malnutrition, either as an inpatient or outpatient, within thepast 3 months

  3. Known chronic medical illness such as severe cerebral palsy, severe congenitalanomalies such as unrepaired congenital heart disease, Down syndrome, hydrocephalus,unrepaired cleft lip or palate, or other conditions that would be expected tocontribute to difficulty feeding the prescribed amounts of therapeutic orsupplementary food

Study Design

Total Participants: 2400
Treatment Group(s): 3
Primary Treatment: Amoxicillin
Phase:
Study Start date:
September 25, 2023
Estimated Completion Date:
September 25, 2026

Connect with a study center

  • Sekota

    Sekota, Amhara
    Ethiopia

    Site Not Available

  • Teltele

    Teltele, Oromia
    Ethiopia

    Active - Recruiting

  • Gode

    Gode, Somali Region
    Ethiopia

    Active - Recruiting

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