Menu
Not yet recruiting 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

No phase Interventional Severe Acute Malnutrition in Childhood Malnutrition, Child Neurocognition, Child

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lipid-Optimized Ready to Use Therapeutic Food (RUTF), Ready to Use Therapeutic Food (RUTF).
Who it may be relevant to
Registry conditions: Severe Acute Malnutrition in Childhood, Malnutrition, Child, Neurocognition, Child. Basic parameters: 6 months — 59 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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)

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.

Primary outcome measures

  • 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]
Secondary outcome measures (8)
  • Change in MDAT Scores after 8 and 12 weeks of treatment [Time frame: 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]
  • Time to Recovery from Moderate Acute Malnutrition [Time frame: 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]
  • Proportion of Participants with Relapse of Severe Acute Malnutrition [Time frame: 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]
  • Incidence of Adverse Events [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Aga Khan University — Karachi

Identifiers

NCT: NCT07345884 · IRB-25-1096

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗