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NCT06781918: BRIGHTSAM
Severe Acute Malnutrition and Child Development Clinical Trial in Mwanza
Phase 3 trial testing Ready to Use Therapeutic Food (RUTF) in Severe Acute Malnutrition in Childhood in 800 participants. Not yet recruiting.
14 November 2025
Quick facts
| Lead sponsor | National Institute for Medical Research, Tanzania |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 800 |
| Start date | 3 February 2025 |
| Primary completion | 14 November 2025 |
| Estimated completion | 14 May 2026 |
| Sites | 1 location across Tanzania |
Drugs / interventions tested
- Ready to Use Therapeutic Food (RUTF) — full drug profile →
- Psychosocial stimulation
Conditions studied
- Severe Acute Malnutrition in Childhood — all drugs for Severe Acute Malnutrition in Childhood →
Sponsor
National Institute for Medical Research, Tanzania
Who can join
Adults 6 Months to 36 Months, any sex, with Severe Acute Malnutrition in Childhood. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized clinical trial to learn whether ready-to-use therapeutic foods enriched with choline and docosahexaenoic acid (DHA) together with psychosocial stimulating activities work well to improve child development in children with severe acute malnutrition(SAM). The overall question this trial aims to answer is can the health and development outcomes of children with SAM be improved through optimized nutritional treatment and integrated psychosocial support. Researchers will compare the new ready-to-use therapeutic food and an integrated psychosocial stimulation to a standard look-alike nutritional supplement that contains no additional nutrients being investigated and the standard nutritional counseling given locally and assess its effects on child development in children with severe acute malnutrition. Participants will: * Be given the trial interventions which will be delivered over 12 weeks * After the 12 weeks of intervention, participants will return for outcome evaluations (week 12 study visit), which will be repeated at follow-up visits after 24 and 48 weeks.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06781918
- 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 in Childhood
Currently open trials in the same condition.
- NCT07026682 — Comparison of Low Osmolar ORS and ReSoMal for Treating Acute Watery Diarrhea in Severely Malnourished Children Aged 6 Mo · NA · active not recruiting
Other National Institute for Medical Research, Tanzania trials
Trials by the same sponsor.
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- NCT03713502 — Enteropathy and Diabetes in HIV Patients · unknown
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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 NCT06781918 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute for Medical Research, Tanzania
- Last refreshed: 17 January 2025
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/NCT06781918.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing