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Completed

NCT Number: NCT07130877

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

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).

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Key information

Conditions

Severe Acute Malnutrition Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital and Institute of child health Multan, Multan, Punjab Province, Pakistan

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WHO F100

Dietary Supplement

WHO F1OO

WHO RECIPE BASED F100

Dietary Supplement

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.

Primary outcomes

  1. Mean weight gain (g/kg/day) during rehabilitation

    Time frame: From randomization to after starting treatment 10 days

    Mean weight gain (g/kg/day) during 10 days of rehabilitation

Secondary outcomes

  1. MUAC

    Time frame: From randomization to after starting treatment 10 days

    Improvement of F MUAC

  2. Safety profile

    Time frame: 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

  3. Acceptability and Palatability by Hedonic scale scores for taste and acceptability of F-100

    Time frame: day 1

    Palatability assessed using a 5-point Hedonic Scale adapted for pediatric populations. Scores collected on day 1

  4. Change in serum albumin levels from baseline to day 10

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital and Institute of Child Health, Multan

Other Gov

Registry information

Official study title

EFFICACY AND SAFETY OF F100 PREPARED BY RECIPE METHOD FOR WEIGHT GAIN IN SEVERELY ACUTE MALNOURISHED CHILDREN

Acronym: REFINE-SAM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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