NCT07130877

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Children's Hospital and Institute of Child Health, Multan · Other Government
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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).

Conditions

• Severe Acute Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	WHO F100	WHO F1OO
DIETARY_SUPPLEMENT	WHO RECIPE BASED F100	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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-06-01
• Completion: 2025-06-30
• First posted: 2025-08-19
• Last updated: 2025-08-24

Locations

2 sites across 1 country: Pakistan