# Tralement vs. Fixed-dose Trace Element Combination Product in Patients >3 to 17 Years of Age Requiring Long-term PN

> **NCT05677126** · PHASE4 · WITHDRAWN · sponsor: **American Regent, Inc.**

## Conditions studied

- Manganese Safety in Pediatric Patients

## Interventions

- **DRUG:** Tralement
- **DRUG:** Fixed-dose trace element combination product of zinc, copper, and selenious acid

## Key facts

- **NCT ID:** NCT05677126
- **Lead sponsor:** American Regent, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** WITHDRAWN
- **Start date:** 2024-08
- **Primary completion:** 2024-08
- **Final completion:** 2024-08-26
- **Target enrollment:** 0 (ACTUAL)
- **Why stopped:** The Tralement Pediatric Safety Study has faced significant challenges in site recruitment and feasibility
- **Last updated:** 2024-11-15


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05677126

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05677126, "Tralement vs. Fixed-dose Trace Element Combination Product in Patients >3 to 17 Years of Age Requiring Long-term PN". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT05677126. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*