Modified Dosage for Severe Acute Malnutrition (MODAM-SAM)

Action Against Hunger USA

Status: Enrolling

Conditions: Severe Acute Malnutrition

Treatments: Dietary Supplement: ready-to-use therapeutic food (RUTF); Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT06061484

MODAM-SAM

Details and patient eligibility

About

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.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,400 participants in 3 patient groups

Control Group

Active Comparator group

Description:

Standard weight-based dosing of Ready-to-Use Therapeutic Food (RUTF) at a dose of 150-200 kcal/kg/day

Treatment:

Drug: Amoxicillin

Dietary Supplement: ready-to-use therapeutic food (RUTF)

SAM Experimental A

Experimental group

Description:

2 sachets (1000 kcal) of RUTF per day

Treatment:

Drug: Amoxicillin

Dietary Supplement: ready-to-use therapeutic food (RUTF)

SAM Experimental B

Experimental group

Description:

2 sachets (1000 kcal) per day while MUAC \< 115mm and/or edema and/or WHZ \< -3; then decreasing to 1 sachet (500 kcal) per day while MUAC 115-124 and WHZ -2 to -3 and no edema

Treatment:

Drug: Amoxicillin

Dietary Supplement: ready-to-use therapeutic food (RUTF)