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

Children's Hospital and Institute of Child Health, Multan

Status: Completed

Conditions: Severe Acute Malnutrition

Treatments: Dietary Supplement: WHO RECIPE BASED F100; Dietary Supplement: WHO F100

Study type: Interventional

Funder types: Other

Identifiers

NCT07130877

U1111-1326-4619

Details and patient eligibility

About

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).

Full 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).

Enrollment: 114 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 2 patient groups

WHO F-100 Formula

Active Comparator group

Description:

WHO already 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.

Treatment:

Dietary Supplement: WHO F100

WHO RECIPE MADE F100

Experimental group

Description:

Who recipe made F100 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.

Treatment:

Dietary Supplement: WHO RECIPE BASED F100