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NCT Number: NCT07345884

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

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)

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Key information

Conditions

Severe Acute Malnutrition in Childhood Child Nutrition Disorders Malnutrition, Child Neurocognition, Child Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University

Karachi, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: UNICEF RUTF, Standard RUTF

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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).

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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.

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Moutwakil

CONTACT

[email protected]

4244853200

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Aga Khan University

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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