Modified Dosage for Severe Acute Malnutrition

Action Against Hunger USA2,400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,400

Conditions

Severe Acute Malnutrition

Interventions

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 Months

Medical Language ↔ Plain English

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

Locations (3)

Sekota

Sekota, Amhara, Ethiopia

NOT_YET_RECRUITING

Teltele

Teltelē, Oromiya, Ethiopia

RECRUITING

Gode

Gode, Somali, Ethiopia

RECRUITING

Outcomes

Primary Outcomes

short-term nutritional recovery from severe acute malnutrition (SAM)

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

Time frame: up to 16 weeks

Secondary Outcomes

weight gain during treatment

Time frame: weekly for up to 16 weeks

MUAC gain during treatment

Time frame: weekly for up to 16 weeks

length/height gain during treatment

Time frame: weekly for up to 16 weeks

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

Time frame: up to weekly for up to 16 weeks

changes to extracellular water (ECW) as measured by bioelectrical impedance analysis

Time frame: up to weekly for up to 16 weeks

changes to total body water (TBW) as measured by bioelectrical impedance analysis

Time frame: up to weekly for up to 16 weeks

changes to fat free mass as measured by bioelectrical impedance analysis

Time frame: up to weekly for up to 16 weeks

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

Time frame: up to weekly for up to 16 weeks

rates of acute illness, including diarrhea, vomiting, and fever during treatment

Time frame: weekly for up to 16 weeks

mortality

Time frame: up to 16 weeks

hospitalization

Time frame: up to 16 weeks

duration of treatment required prior to short-term recovery

Time frame: up to 16 weeks

medium-term vital status

calculated as number of children who die divided by total number of children initially enrolled