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

NCT07345884 | Not Yet Recruiting DMC

• 1 other identifier: IRB-25-1096
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

RUTF; Ready-to-use therapeutic food

Outcome Measures

Primary Outcomes (1)

• 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).

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (8)

• Change in MDAT Scores after 8 and 12 weeks of treatment

  Baseline and after 8 and 12 weeks of treatment

• Time to Recovery from Severe Acute Malnutrition

  From enrollment to the end of the study period at 12 weeks

• Time to Recovery from Moderate Acute Malnutrition

  From enrollment to the end of the study period at 12 weeks

• Proportion of Participants with Relapse of Moderate Acute Malnutrition

  From enrollment to the end of the study period at 12 weeks

• Proportion of Participants with Relapse of Severe Acute Malnutrition

  From enrollment to the end of the study period at 12 weeks

Other Outcomes (1)

• Mortality rate of participants

  From enrollment to the end of study period at 12 weeks

Study Arms (2)

LO-RUTF

EXPERIMENTAL

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)

RUTF

ACTIVE COMPARATOR

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)

Interventions

Lipid-Optimized Ready to Use Therapeutic Food (RUTF) DIETARY_SUPPLEMENT

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.

LO-RUTF

Ready to Use Therapeutic Food (RUTF) DIETARY_SUPPLEMENT

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

Also known as: UNICEF RUTF, Standard RUTF

RUTF

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Aga Khan University: collaborator

Study Sites (1)

Aga Khan University

Karachi, Pakistan

Location

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Kiran K Masood, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Mohid Khan

  The Satya Nutrition Foundation

  STUDY DIRECTOR

• 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 CHAIR

• Amith Umesh

  The Satya Nutrition Foundation

  STUDY DIRECTOR

Central Study Contacts

Ahmed Moutwakil

CONTACT

4244853200; amoutwakil@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Model Details: Participants in both interventions will receive approximately 190 kcal/kg/day of LO-RUTF or standard RUTF. The standard RUTF will be produced internationally and shipped to Pakistan. The alternative treatment for SAM, LO-RUTF, is produced locally in Pakistan.

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 16, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)