RECIPE BASED F100 INTERVENTION FOR NUTRITIONAL EFFICACY IN SAM (REFINE-SAM )

EFFICACY AND SAFETY OF F100 PREPARED BY RECIPE METHOD FOR WEIGHT GAIN IN SEVERELY ACUTE MALNOURISHED CHILDREN

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).

Inclusion Criteria:

• Children aged 6-59 months
• Diagnosed with SAM
• Have completed stabilization and entering rehabilitation phase per WHO CMAM guidelines

Exclusion Criteria:

• Secondary malnutrition (e.g. tuberculosis, HIV)
• Chronic systemic diseases
• Congenital anomalies
• Terminal illness