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NCT05319717

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

Completed Phase 2 Last updated 7 June 2024
What this trial tests

Phase 2 trial testing Ready-to-use therapeutic food with heat stabilized rice bran in Severe Acute Malnutrition in 200 participants. Completed in 31 August 2023.

Timeline
1 December 2022
Primary endpoint
31 August 2023
31 August 2023

Quick facts

Lead sponsorColorado State University
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment200
Start date1 December 2022
Primary completion31 August 2023
Estimated completion31 August 2023
Sites1 location across Indonesia

Drugs / interventions tested

Conditions studied

Sponsor

Colorado State University

Who can join

Adults 6 Months to 59 Months, any sex, with Severe Acute Malnutrition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Solutions to Enhance Health with Alternative Treatments (SEHAT) protocol: a double-blinded randomised controlled trial for gut microbiota-targeted treatment of severe acute malnutrition using rice bran in ready-to-use therapeutic foods in Indonesia.
    Weber AM, Barbazza S, Fauzi MD, Rachmadewi A, et al · · 2023 · cited 1× · PMID 38000818 · DOI 10.1136/bmjopen-2023-076805
  2. Inclusion of stabilised rice bran in ready-to-use therapeutic food supports growth in Indonesian children with severe and moderate acute malnutrition: solutions to enhance health with alternative treatments (SEHAT), a double-blinded, randomised clinical trial.
    Barbazza S, Weber AM, Fauzi MD, Rachmadewi A, et al · · 2026 · PMID 41737350 · DOI 10.1017/jns.2025.10074
  3. Rice Bran Supplements the Nutritional Density of Ready-to-Use Therapeutic Foods: A Targeted Nutrient and Non-Targeted Metabolomic Analysis.
    Weber AM, Bovaird ES, Toulabi SB, Barbazza S, et al · · 2026 · PMID 41583016 · DOI 10.1002/fsn3.71448

Verify or expand the search:

Other recruiting trials for Severe Acute Malnutrition

Currently open trials in the same condition.

Other Colorado State University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing