Health TrialsbyHealthPanel

Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM)

ConditionModerate Acute Malnutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-59
SponsorAction Against Hunger USA

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ready-to-use supplementary food (RUSF)

    Dietary supplement

    standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/media/16636/file/S0000248-RUSF-Specification.pdf

  • ready-to-use therapeutic food (RUTF)

    Dietary supplement

    standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf

Treatment groups

2,400 Participants
are divided into 3 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: MAM Experimental AExperimental treatment 1 intervention
Group C: MAM Experimental BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

short-term nutritional recovery from MAM

two consecutive weeks with MUAC \> 12.4 cm and/or WHZ \>= -2, depending on enrollment criteria

Time frame
up to 16 weeks

Secondary outcomes

1

weight gain during treatment

Time frame
weekly for up to 16 weeks
2

mid-upper-arm circumference (MUAC) gain during treatment

Time frame
weekly for up to 16 weeks
3

length/height gain during treatment

Time frame
weekly for up to 16 weeks
4

changes to phase angle (PhA) as measured by bioelectrical impedance analysis

Time frame
up to weekly for up to 16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Action Against Hunger USA

Lead sponsor

University of Washington

Collaborator

Ethiopian Public Health Institute

Collaborator

Source ClinicalTrials.gov
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