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

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)

Conditions

• Severe Acute Malnutrition in Childhood
• Malnutrition, Child
• Neurocognition, Child

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.

Sponsors & Collaborators

• Aga Khan University

  collaborator OTHER

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Kiran K Masood, MD · University of California, Los Angeles

• Mohid Khan · The Satya Nutrition Foundation

• Samir Ismail · The Satya Nutrition Foundation

• Akhila Annadanam · The Satya Nutrition Foundation

• Tu Nguyen · The Satya Nutrition Foundation

• Fatima Ahmad · The Satya Nutrition Foundation

• Meghana Dantuluri · The Satya Nutrition Foundation

• Amith Umesh · The Satya Nutrition Foundation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2026-08-31

Completion

2026-10-31

Countries

• Pakistan

Study Locations