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This open-label randomized controlled trial evaluates the efficacy and safety of multiple formulations of the F-100 therapeutic feed during the rehabilitation phase among children aged 6-59 months with SAM, in comparison to standard WHO F-100. The primary outcome is daily weight gain (g/kg/day) over 10 days; secondary outcomes include MUAC improvement, gastrointestinal tolerance (vomiting/diarrhea), duration to recovery, and renal safety markers (serum urea, creatinine, serum sodium, urine-specific gravity).
This open-label randomized controlled trial evaluates the efficacy and safety of multiple formulations of the F-100 therapeutic feed during the rehabilitation phase among children aged 6-59 months with SAM, in comparison to standard WHO F-100. The study includes four arms: the WHO commercial F-100 powder (control), recipe-based locally prepared F-100 (Arm A), diluted F-100 (Arm B), and an alternative locally prepared high-energy RUTF-like blend (Arm C). The primary outcome is daily weight gain (g/kg/day) over 10 days; secondary outcomes include MUAC improvement, gastrointestinal tolerance (vomiting/diarrhea), duration to recovery, and renal safety markers (serum urea, creatinine, serum sodium, urine-specific gravity).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WHO F-100 Formula | Active Comparator | WHO already made formula will be given after initial stabilization starting from 150 kcal per kg per day to a maximum of 220 kcal per kg per day at 4-hourly intervals, and intakes and vitals will be monitored. |
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| WHO RECIPE MADE F100 | Experimental | Who recipe made F100 formula will be given after initial stabilization, starting from 150 kcal per kg per day to a maximum of 220 kcal per kg per day at 4-hourly intervals, and intakes and vitals will be monitored. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WHO F100 | Dietary Supplement | WHO F1OO |
| |
| WHO RECIPE BASED F100 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean weight gain (g/kg/day) during rehabilitation | Mean weight gain (g/kg/day) during 10 days of rehabilitation | From randomization to after starting treatment 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| MUAC | Improvement of F MUAC | From randomization to after starting treatment 10 days |
| Safety profile | Incidence of treatment-related adverse events (nausea, vomiting, and fluid overload) assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad T Sultan, PhD | Bahuddin Zakariya University,Multan. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital and Institute of child health Multan | Multan | Punjab Province | 60000 | Pakistan | ||
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| Label | URL |
|---|---|
| Munirul Islam MM, Dafni M, et al. Efficacy of F-100, diluted F-100 (F100D), and infant formula as rehabilitation diet for infants aged \< 6 months with severe acute malnutrition: a randomized clinical trial. Eur J Nutr. 2020 | View source |
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| ID | Term |
|---|---|
| D000067011 | Severe Acute Malnutrition |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Dietary Supplement |
Recipe-made formula will be given after initial stabilization, starting from 150 kcal per kg per day to a maximum of 220 kcal per kg per day at 4-hourly intervals, and intakes and vitals will be monitored. |
|
| From randomization to after starting treatment 10 days |
| Acceptability and Palatability by Hedonic scale scores for taste and acceptability of F-100 | Palatability assessed using a 5-point Hedonic Scale adapted for pediatric populations. Scores collected on day 1 | day 1 |
| Change in serum albumin levels from baseline to day 10 | Serum albumin measured in g/dL using a standard automated biochemical analyzer. Change calculated as day 10 value minus baseline value. | base line and day 10 |
| Tehsil Head Quater Sujah Abad |
| Multan Khurd |
| Punjab Province |
| 60000 |
| Pakistan |