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

NCT05677126 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-11-15

No results posted yet for this study

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.

Conditions

  • Manganese Safety in Pediatric Patients

Interventions

DRUG

Tralement

Tralement with Manganese

DRUG

Fixed-dose trace element combination product of zinc, copper, and selenious acid

Tralement without Manganese

Sponsors & Collaborators

  • American Regent, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Falone, MD · Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2024-08-31
Completion
2024-08-26
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05677126 on ClinicalTrials.gov