Treatment of Severe Acute Malnutrition in Children 6 to 59 Months Old With Standard Ready To Use Therapeutic Food Compared to a Newly Formulated Lipid Optimized Ready To Use Therapeutic Food

N/ANot Yet RecruitingNCT07345884

University of California, Los Angeles125 enrolled

Overview

The goal of this randomized clinical trial is to learn if a newly formulated Lipid-Optimized Ready-to-Use Therapeutic Food (LO-RUTF) can treat severe acute malnutrition in children aged 6 to 59 months. The main questions it aims to answer are: 1. Does LO-RUTF impact physical recovery from severe acute malnutrition in participants? 2. Does LO-RUTF impact neurocognitive performance after 8 and 12 weeks of treatment? Researchers will compare LO-RUTF to standard RUTF see if our energy-dense food compares to standard issue RUTF in terms of promoting recovery from severe acute malnutrition. Participants will * Take a one-week ration of LO-RUTF or standard RUTF based on the participant's weight * Return every week for checkups, tests and to receive the next ration of assigned RUTF if eligible * Be assessed for neurocognitive function through Malawi Developmental Assessment Tool (MDAT) at three time points (before treatment, 4 weeks, 8 weeks)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

125

Conditions

Severe Acute Malnutrition in Childhood Malnutrition, Child Neurocognition, Child

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Children aged 6-59 months with severe acute malnutrition, i.e., MUAC \<11.5 cm, and/or weight-for-height/length z-score \< -3, and/or with bilateral pitting edema, with an appetite to completely consume a 30 g test feeding, and without medical complications presenting at selected rural therapeutic feeding health facilities Exclusion Criteria: * Children that are simultaneously involved in another research trial or supplemental feeding program, are developmentally delayed, have vision or hearing deficits, or have a history of milk or peanut allergy. * Chronic diseases such as malabsorption, chronic kidney disease, inflammatory bowel disease, congenital heart disease, endocrine disorders (e.g., hypothyroidism, growth hormone deficiencies), recurrent infections (e.g., pneumonia, cough, fever, pharyngitis), chronic respiratory diseases (e.g., asthma, lung diseases), congenital or acquired immunodeficiency, and neurological disorders

Outcomes

Primary Outcomes

Number of Participants Recovered from Severe Acute Malnutrition as Assessed by WHO Anthro v3.1

The primary outcome is recovery from SAM, deﬁned as: mid-upper arm circumference ≥ 11.5cm (for two consecutive weekly visits), and/or weight-for-height/length z-score \> -3 SD, and/or no bilateral pitting edema (for two consecutive weekly visits).

Time frame: From enrollment to the end of treatment at 8 weeks

Secondary Outcomes

Change in MDAT Scores after 8 and 12 weeks of treatment

The global development score along with all subdomain scores of the MDAT will be used as a measure of neurocognitive performance. with a higher score indicating a better outcome.

Time frame: Baseline and after 8 and 12 weeks of treatment

Time to Recovery from Severe Acute Malnutrition

Defined as time taken to recover from severe acute malnutrition, which is deﬁned as: mid-upper-arm-circumference ≥ 11.5cm (for two consecutive weekly visits), and/or weight-for-height z-score \> -3, and/or no bilateral pitting edema (for two consecutive weekly visits).