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

University of California, Los Angeles (UCLA)

Status: Not yet enrolling

Conditions: Malnutrition, Child; Severe Acute Malnutrition in Childhood; Neurocognition, Child

Treatments: Dietary Supplement: Ready to Use Therapeutic Food (RUTF); Dietary Supplement: Lipid-Optimized Ready to Use Therapeutic Food (RUTF)

Study type: Interventional

Funder types: Other

Identifiers

NCT07345884

IRB-25-1096

Details and patient eligibility

About

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)

Enrollment: 125 estimated patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

125 participants in 2 patient groups

LO-RUTF

Experimental group

Description:

Participants in the LO-RUTF arm will receive approximately 190 kcal/kg/day of Lipid-Optimized Ready to Use Therapeutic Food (RUTF). This RUTF is locally produced and contains maize, milk powder, rice flour, soymeal, sugar, whey isolate, palm oil, flaxseed oil, coconut oil, premix and an emulsifier.

Treatment:

Dietary Supplement: Lipid-Optimized Ready to Use Therapeutic Food (RUTF)

RUTF

Active Comparator group

Description:

Participants in the RUTF arm will receive approximately 190 kcal/kg/day of Ready to Use Therapeutic Food (RUTF). This RUTF produced by UNICEF contains peanut paste, sugar, non-fat dried milk, vegetable oil, a premix containing concentrated minerals and vitamins, and an emulsifier.

Treatment:

Dietary Supplement: Ready to Use Therapeutic Food (RUTF)