drugset / Trial / NCT05677126
Tralement vs. Fixed-dose Trace Element Combination Product in Patients >3 to 17 Years of Age Requiring Long-term PN
RandomizedParallel-groupTriple-blindTreatment
Summary
Tralement versus a fixed-dose trace element combination product of zinc, copper, and selenious acid to evaluate product safety in pediatric patients \>3 to 17 years of age requiring long-term parenteral nutrition.
Timeline
- Start
- 2024-08
- Primary completion
- 2024-08
- Completion
- 2024-08-26
Outcome
Outcome not reported
Stopped (Enrollment): “The Tralement Pediatric Safety Study has faced significant challenges in site recruitment and feasibility”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tralement | Unknown | — | — |
| Comparator | Zinc Sulfate | Unknown | — | — |
| Comparator | copper | Other / unclassified | — | — |
| Comparator | selenious acid | Unknown | — | — |
Indications
No indication recorded.