Severe Acute Malnutrition
Conditions
Keywords
F100, Recipe-based formula, Therapeutic feeding
Brief 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).
Interventions
DIETARY_SUPPLEMENTWHO F100
WHO F1OO
DIETARY_SUPPLEMENTWHO 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.
Sponsors
Children's Hospital and Institute of Child Health, Multan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean weight gain (g/kg/day) during rehabilitation | From randomization to after starting treatment 10 days | Mean weight gain (g/kg/day) during 10 days of rehabilitation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MUAC | From randomization to after starting treatment 10 days | Improvement of F MUAC |
| Safety profile | From randomization to after starting treatment 10 days | Incidence of treatment-related adverse events (nausea, vomiting, and fluid overload) assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0 |
| Acceptability and Palatability by Hedonic scale scores for taste and acceptability of F-100 | day 1 | Palatability assessed using a 5-point Hedonic Scale adapted for pediatric populations. Scores collected on day 1 |
| Change in serum albumin levels from baseline to day 10 | base line and day 10 | Serum albumin measured in g/dL using a standard automated biochemical analyzer. Change calculated as day 10 value minus baseline value. |
Countries
Pakistan
Outcome results
None listed