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Trial of Rice-Based F-75 in Severe Malnutrition & Persistent Diarrhea in Children (SAM-RICE Study)

NCT07070856 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2025-08-24

No results posted yet for this study

Summary

The goal of this study is to find out if a rice-based version of the F-75 therapeutic food helps children with severe acute malnutrition (SAM) and persistent diarrhea recover better than the standard commercial F-75.

The main questions it aims to answer are:

1. Does rice-based F-75 reduce the duration of diarrhea and improve nutritional recovery in children with SAM?
2. Is rice-based F-75 as safe and well-tolerated as the standard WHO F-75?

Researchers will compare two groups:

One group will receive the new rice-based F-75. The other group will receive the standard F-75.

Participants will:

1. Be children aged 6 to 59 months admitted with SAM and persistent diarrhea
2. Be randomly assigned to one of the two feeding groups
3. Stay in a hospital ward for monitoring during the stabilization phase

Be assessed daily for:

Stool frequency Weight changes Appetite Medical problems or side effects

This study will help determine whether the rice-based F-75 is a better option for malnourished children with diarrhea.

Conditions

  • Severe Acute Malnutrition
  • Persistent Diarrhea
  • Children

Interventions

DIETARY_SUPPLEMENT

WHO-recommended standard therapeutic milk used for stabilization phase in SAM)

F75 GIVEN INITIALLY 2HOURLY,130 ml per kg than 3 and 4hourly maximum takes 5 to 7 days.

DIETARY_SUPPLEMENT

HO-recommended Rice based therapeutic milk used for stabilization phase in SAM)

Rice based F75 GIVEN INITIALLY 2HOURLY,130 ml per kg than 3 and 4hourly maximum takes 5 to 7 days.

Sponsors & Collaborators

  • Children's Hospital and Institute of Child Health, Multan

    lead OTHER_GOV

Principal Investigators

  • Muhammad T Sultan, PhD · Bahauddin zakariya University,Multan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07070856 on ClinicalTrials.gov