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Tralement Versus a Fixed-dose Trace Element Combination Product to Evaluate Manganese Safety

NCT05661682 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-02-12

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 adult patients requiring long-term parenteral nutrition.

Conditions

  • Manganese Safety in Adults

Interventions

DRUG

Tralement

Tralement with Manganese Sulfate

DRUG

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

Tralement without Manganese Sulfate

Sponsors & Collaborators

  • American Regent, Inc.

    lead INDUSTRY

Principal Investigators

  • Khaled Khechen, MD · Sr. Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-10-31
Completion
2026-12-04
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 NCT05661682 on ClinicalTrials.gov