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)
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
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
Parallel
Lipid-Optimized Ready to Use Therapeutic Food (RUTF)
Dietary supplementSince 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 supplementThis is the standard of care RUTF with UNICEF product specifications. This RUTF will be produced internationally and shipped to Pakistan.
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).
Change in MDAT Scores 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.
Time to Recovery from Severe Acute Malnutrition
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).
Time to Recovery from Moderate Acute Malnutrition
Defined as time taken to achieve a mid-upper-arm-circumference ≥12.5 cm
Proportion of Participants with Relapse of Moderate Acute Malnutrition
Participants developing moderate acute malnutrition at any point after achieving recovery from severe acute malnutrition compared to all participants
Mortality rate of participants
Frequency of deaths among participants within study period
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University of California, Los Angeles
Lead sponsor
Aga Khan University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
