Severe Acute Malnutrition in Childhood, Malnutrition, Child, Neurocognition, Child
Conditions
Keywords
RUTF, Ready-to-use therapeutic food
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: 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_SUPPLEMENTLipid-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_SUPPLEMENTReady 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.
Sponsors
University of California, Los Angeles
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Recovered from Severe Acute Malnutrition as Assessed by WHO Anthro v3.1 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in MDAT Scores after 8 and 12 weeks of treatment | 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. |
| Time to Recovery from Severe Acute Malnutrition | 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). |
| Time to Recovery from Moderate Acute Malnutrition | 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 |
| Proportion of Participants with Relapse of Moderate Acute Malnutrition | 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 |
| Proportion of Participants with Relapse of Severe Acute Malnutrition | 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 |
| Number of Participants with Non-Responder Status | 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. |
| Incidence of Adverse Events | 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 |
| Incidence of Hypercalcemia, Hypervitaminosis D, or excessive DHA concentrations | 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. |
Countries
Pakistan
Contacts
CONTACTAhmed Moutwakil
PRINCIPAL_INVESTIGATORKiran K Masood, MD
University of California, Los Angeles
STUDY_DIRECTORMohid Khan
The Satya Nutrition Foundation
STUDY_CHAIRSamir Ismail
The Satya Nutrition Foundation
STUDY_CHAIRAkhila Annadanam
The Satya Nutrition Foundation
STUDY_CHAIRTu Nguyen
The Satya Nutrition Foundation
STUDY_CHAIRFatima Ahmad
The Satya Nutrition Foundation
STUDY_CHAIRMeghana Dantuluri
The Satya Nutrition Foundation
STUDY_DIRECTORAmith Umesh
The Satya Nutrition Foundation
Outcome results
None listed