Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Aga Khan University | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LO-RUTF | Experimental | Participants in the LO-RUTF arm will receive approximately 190 kcal/kg/day of Lipid-Optimized Ready to Use Therapeutic Food (RUTF). This RUTF is locally produced and contains maize, milk powder, rice flour, soymeal, sugar, whey isolate, palm oil, flaxseed oil, coconut oil, premix and an emulsifier. |
|
| RUTF | Active Comparator | Participants in the RUTF arm will receive approximately 190 kcal/kg/day of Ready to Use Therapeutic Food (RUTF). This RUTF produced by UNICEF contains peanut paste, sugar, non-fat dried milk, vegetable oil, a premix containing concentrated minerals and vitamins, and an emulsifier. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and after 8 and 12 weeks of treatment |
| Time to Recovery from Severe Acute Malnutrition |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate of participants | Frequency of deaths among participants within study period | From enrollment to the end of study period at 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Moutwakil | Contact | 4244853200 | amoutwakil@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kiran K Masood, MD | University of California, Los Angeles | Principal Investigator |
| Mohid Khan | The Satya Nutrition Foundation | Study Director |
| Samir Ismail |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University | Karachi | Pakistan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| 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. |
|
|
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). |
| From enrollment to the end of the study period at 12 weeks |
| Time to Recovery from Moderate Acute Malnutrition | Defined as time taken to achieve a mid-upper-arm-circumference ≥12.5 cm | From enrollment to the end of the study period at 12 weeks |
| 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 | From enrollment to the end of the study period at 12 weeks |
| Proportion of Participants with Relapse of Severe Acute Malnutrition | Participants developing severe acute malnutrition at any point after achieving recovery from severe acute malnutrition compared to all participants | From enrollment to the end of the study period at 12 weeks |
| Number of Participants with Non-Responder Status | 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. | From enrollment to the end of the study period at 12 weeks |
| Incidence of Adverse Events | Number of participants with any adverse events, including those judged to be related to the study RUTF | From enrollment to the end of the study period at 12 weeks |
| Incidence of Hypercalcemia, Hypervitaminosis D, or excessive DHA concentrations | Determined by biochemical assessments at 8 weeks to evaluate serum 25-hydroxyvitamin D, calcium, and DHA concentrations. | From baseline to the end of treatment at 8 weeks |
| The Satya Nutrition Foundation |
| Study Chair |
| Akhila Annadanam | The Satya Nutrition Foundation | Study Chair |
| Tu Nguyen | The Satya Nutrition Foundation | Study Chair |
| Fatima Ahmad | The Satya Nutrition Foundation | Study Chair |
| Meghana Dantuluri | The Satya Nutrition Foundation | Study Chair |
| Amith Umesh | The Satya Nutrition Foundation | Study Director |
| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided