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

April 20, 2026 updated by: Ahmed Moutwakil, University of California, Los Angeles

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

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
      • Karachi, Pakistan
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LO-RUTF
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.
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.
Active Comparator: RUTF
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.
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.
Other Names:
  • Standard RUTF
  • UNICEF RUTF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Recovered from Severe Acute Malnutrition as Assessed by WHO Anthro v3.1
Time Frame: From enrollment to the end of treatment at 8 weeks
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).
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in MDAT Scores after 8 and 12 weeks of treatment
Time Frame: Baseline and 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.
Baseline and after 8 and 12 weeks of treatment
Time to Recovery from Severe Acute Malnutrition
Time Frame: From enrollment to the end of the study period at 12 weeks
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).
From enrollment to the end of the study period at 12 weeks
Time to Recovery from Moderate Acute Malnutrition
Time Frame: From enrollment to the end of the study period at 12 weeks
Defined as time taken to achieve a mid-upper-arm-circumference ≥12.5 cm
From enrollment to the end of the study period at 12 weeks
Proportion of Participants with Relapse of Moderate Acute Malnutrition
Time Frame: From enrollment to the end of the study period at 12 weeks
Participants developing moderate acute malnutrition at any point after achieving recovery from severe acute malnutrition compared to all participants
From enrollment to the end of the study period at 12 weeks
Proportion of Participants with Relapse of Severe Acute Malnutrition
Time Frame: From enrollment to the end of the study period at 12 weeks
Participants developing severe acute malnutrition at any point after achieving recovery from severe acute malnutrition compared to all participants
From enrollment to the end of the study period at 12 weeks
Number of Participants with Non-Responder Status
Time Frame: From enrollment to the end of the study period at 12 weeks
Participants who have not met the SAM exit criteria after 3 months (MUAC > 11.5 cm, clinically well, > 15 % weight gain, and no oedema for two consecutive visits) will receive a non-responder outcome.
From enrollment to the end of the study period at 12 weeks
Incidence of Adverse Events
Time Frame: From enrollment to the end of the study period at 12 weeks
Number of participants with any adverse events, including those judged to be related to the study RUTF
From enrollment to the end of the study period at 12 weeks
Incidence of Hypercalcemia, Hypervitaminosis D, or excessive DHA concentrations
Time Frame: From baseline to the end of treatment at 8 weeks
Determined by biochemical assessments at 8 weeks to evaluate serum 25-hydroxyvitamin D, calcium, and DHA concentrations.
From baseline to the end of treatment at 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate of participants
Time Frame: From enrollment to the end of study period at 12 weeks
Frequency of deaths among participants within study period
From enrollment to the end of study period at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Aga Khan University

Investigators

  • Principal Investigator: Kiran K Masood, MD, University of California, Los Angeles
  • Study Director: Mohid Khan, The Satya Nutrition Foundation
  • Study Chair: Samir Ismail, The Satya Nutrition Foundation
  • Study Chair: Akhila Annadanam, The Satya Nutrition Foundation
  • Study Chair: Tu Nguyen, The Satya Nutrition Foundation
  • Study Chair: Fatima Ahmad, The Satya Nutrition Foundation
  • Study Chair: Meghana Dantuluri, The Satya Nutrition Foundation
  • Study Director: Amith Umesh, The Satya Nutrition Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-25-1096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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