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NOT YET RECRUITING
NCT07345884
NA

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

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

Summary

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, 12 weeks)

Official title: Comparison of Treatment of Severe Acute Malnutrition in Children 6 to 59 Months Old With Standard Ready To Use Therapeutic Food and Newly Formulated Lipid Optimized Ready To Use Therapeutic Food an Individual Randomized Double Blind Controlled Trial

Key Details

Gender

All

Age Range

6 Months - 59 Months

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2026-02

Completion Date

2026-06

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Lipid-Optimized Ready to Use Therapeutic Food (RUTF)

Since this is a pilot trial for the study recipe, we have increased the vitamin D3 content in this RUTF as an experimental variable within this study.

DIETARY_SUPPLEMENT

Ready to Use Therapeutic Food (RUTF)

This is the standard of care RUTF with UNICEF product specifications. This RUTF will be produced internationally and shipped to Pakistan.

Locations (1)

Aga Khan University

Karachi, Pakistan