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Rice Bran-based Supplemental Foods for the Treatment of Childhood Malnutrition

NCT05319717 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-06-07

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy of treating children with severe acute malnutrition (SAM) with a locally produced ready-to-use therapeutic food (RUTF) with or without rice bran.

Conditions

  • Severe Acute Malnutrition

Interventions

DIETARY_SUPPLEMENT

Ready-to-use therapeutic food with heat stabilized rice bran

Children assigned to the experimental group will be treated for severe acute malnutrition with a novel ready-to-use therapeutic food that contains 5% heat stabilized rice bran.

DIETARY_SUPPLEMENT

Ready-to-use therapeutic food (no rice bran)

Children assigned to the active comparator group will be treated for severe acute malnutrition with a novel ready-to-use therapeutic food (no rice bran).

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • Savica, Indonesia

    collaborator UNKNOWN

  • Institute of Research for Development, France

    collaborator OTHER_GOV

  • Colorado State University

    lead OTHER

Principal Investigators

  • Damayanti Soekarjo, PhD · Savica, Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • Indonesia

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 NCT05319717 on ClinicalTrials.gov