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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
114
WHO F1OO
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.
Children's Hospital and Institute of child health Multan
Multan, Punjab Province, Pakistan
Tehsil Head Quater Sujah Abad
Multan Khurd, Punjab Province, Pakistan
Mean weight gain (g/kg/day) during rehabilitation
Mean weight gain (g/kg/day) during 10 days of rehabilitation
Time frame: From randomization to after starting treatment 10 days
MUAC
Improvement of F MUAC
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: base line and day 10
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