Nutritional outcomes and storage stability of standard F-100 versus WHO F-100 in children with severe acute malnutrition: a randomized control trial

This study evaluated the efficacy, safety, and storage stability of the WHO recipe-based F-100 compared to commercial F-100 in children with severe acute malnutrition (SAM) during rehabilitation. A randomized controlled trial enrolled 114 children aged 6–59 months at a Nutrition Stabilization Centre in Multan and randomized them to receive standard WHO F-100 ( n = 57) and WHO recipe-based F-100 ( n = 57) during the rehabilitation phase. Storage stability was assessed over 30 days for microbial load, pH, colour, peroxide value, acid value, and water activity. Both formulations remained within WHO safety thresholds throughout storage. After 10 days of intervention, both groups demonstrated significant improvements in weight and mid-upper arm circumference (MUAC); however, the recipe-based group showed significantly higher weight gain (6.83 ± 0.63 kg), height (65.65 ± 6.59 cm, p < 0.001), and MUAC (9.34 ± 1.29 cm, p < 0.001). Biochemical markers indicated improved protein status and renal function in both groups. Recipe-based F-100 represents an efficacious, shelf-stable, and locally adaptable alternative to WHO F-100 for SAM rehabilitation in resource-constrained settings. Trial registration ClinicalTrials.gov NCT07130877 first posted August 07, 2025.