Language: BG BG
← Back to results
Not yet recruiting Not applicable 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 applicable phase (e.g. observational)
Conditions: Severe Acute Malnutrition in Childhood Malnutrition, Child Neurocognition, Child

Sponsor: University of California, Los Angeles

trial.available_in: БГ
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)
Who can participate
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
Interventions
Lipid-Optimized Ready to Use Therapeutic Food (RUTF)
DIETARY_SUPPLEMENT
Ready to Use Therapeutic Food (RUTF)
DIETARY_SUPPLEMENT
Locations 1
Pakistan (1)
Aga Khan University
Karachi
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
6 Months
Maximum age
59 Months
Healthy volunteers
No
Start date
01.06.2026
Completion date
01.10.2026
Registry ID
NCT07345884
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.