Last reviewed · How we verify
NCT05319717
Rice Bran-based Supplemental Foods for the Treatment of Childhood Malnutrition
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.
31 August 2023
Quick facts
| Lead sponsor | Colorado State University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 December 2022 |
| Primary completion | 31 August 2023 |
| Estimated completion | 31 August 2023 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Ready-to-use therapeutic food with heat stabilized rice bran
- Ready-to-use therapeutic food (no rice bran)
Conditions studied
- Severe Acute Malnutrition — all drugs for Severe Acute Malnutrition →
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):
-
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 -
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 -
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:
- PubMed search for NCT05319717
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Severe Acute Malnutrition
Currently open trials in the same condition.
- NCT06869850 — Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition · NA · recruiting
- NCT07089329 — Efficacy of Striatin in Malnourished Children · Phase 3 · recruiting
- NCT06010719 — Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition · Phase 4 · recruiting
- NCT05994742 — An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM · Phase 3 · active not recruiting
- NCT06593080 — The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis · NA · recruiting
Other Colorado State University trials
Trials by the same sponsor.
- NCT07290309 — Survivors Uniting for Remote Guided Exercise · NA · recruiting
- NCT07297823 — Sex Differences in Cold-Induced Changes in Maximal Fat Oxidation · NA · not yet recruiting
- NCT07228013 — Examining Effects of Active Plant Engagement on College Student Well-Being and Performance · NA · active not recruiting
- NCT06834984 — Ritual Synbiotic+, a Dietary Supplement Designed to Impact Gastrointestinal Health, Mood, and Behavior in Women · NA · recruiting
- NCT06822387 — Health Without Barriers/Salud Sin Barreras- Northern Colorado · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05319717 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Colorado State University
- Last refreshed: 7 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05319717.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing