NCT07130877

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 7, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

August 7, 2025

Last Update Submit

August 22, 2025

Conditions

Severe Acute Malnutrition

Keywords

F100Recipe-based formulaTherapeutic feeding

Outcome Measures

Primary Outcomes (1)

  • Mean weight gain (g/kg/day) during rehabilitation

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

    From randomization to after starting treatment 10 days

Secondary Outcomes (4)

  • MUAC

    From randomization to after starting treatment 10 days

  • Safety profile

    From randomization to after starting treatment 10 days

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

    day 1

  • Change in serum albumin levels from baseline to day 10

    base line and day 10

Study Arms (2)

WHO F-100 Formula

ACTIVE COMPARATOR

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.

Dietary Supplement: WHO F100

WHO RECIPE MADE F100

EXPERIMENTAL

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.

Dietary Supplement: WHO RECIPE BASED F100

Interventions

WHO F100DIETARY_SUPPLEMENT

WHO F1OO

WHO F-100 Formula
WHO RECIPE BASED F100DIETARY_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.

WHO RECIPE MADE F100

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6-59 months
  • Diagnosed with SAM
  • Have completed stabilization and entering rehabilitation phase per WHO CMAM guidelines

You may not qualify if:

  • Secondary malnutrition (e.g. tuberculosis, HIV)
  • Chronic systemic diseases
  • Congenital anomalies
  • Terminal illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital and Institute of child health Multan

Multan, Punjab Province, 60000, Pakistan

Location

Tehsil Head Quater Sujah Abad

Multan Khurd, Punjab Province, 60000, Pakistan

Location

Related Links

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Muhammad T Sultan, PhD

    Bahuddin Zakariya University,Multan.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2025

First Posted

August 19, 2025

Study Start

January 1, 2025

Primary Completion

June 1, 2025

Study Completion

June 30, 2025

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)