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Tralement vs Fixed-Dose Trace Elements in Adult Home Parenteral Nutrition
NCT05661682Phase 4
Key facts
- Status
- Withdrawn
- Start
- Feb 2025
- Primary completion
- Oct 2025
- Sponsor
- American Regent, Inc.
- Modality
- Small Molecules
- Conditions
- trace element deficiency
01
Overview
Phase 4, randomised, single-blind trial of zinc sulfate + cupric sulfate + manganese sulfate + selenious acid in trace element deficiency (2 arms), sponsored by American Regent, Inc. Primary endpoint: Brain deposition of manganese at 6 Months. Planned start Feb 2025; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Tralement
Tralement (with Manganese)
Comparator
Trace Elements (No Manganese)
03
Who it enrols
Adults (18-80) who are new users of home parenteral nutrition anticipated to require it for >= 6 months, with normal baseline brain MRI and blood manganese levels.
04
Endpoints
Primary
Brain deposition of manganese
Secondary
Efficacy & safety of Tralement versus comparator
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