Trials / Completed
CompletedNCT00004338
Study of Zinc for Wilson Disease
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 0 Years
- Healthy volunteers
- Not accepted
Summary
OBJECTIVES: I. Establish the safety and efficacy of extended maintenance zinc therapy in 200 patients with Wilson disease. II. Establish further the role of zinc in the prophylactic treatment of presymptomatic patients by increasing the current cohort from 80 to at least 100 patients. III. Establish further the role of zinc therapy in pregnant patients with Wilson disease. IV. Establish further the role of zinc therapy in children with Wilson disease.
Detailed description
PROTOCOL OUTLINE: Patients receive copper regulation therapy with zinc acetate: an existing cohort on maintenance therapy will be followed for long-term data collection; presymptomatic patients are treated prophylactically; and pregnant patients are evaluated for fetal outcome. All patients are evaluated for copper balance, clinical control, and toxicity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | zinc acetate |
Timeline
- Start date
- 1993-10-01
- First posted
- 1999-10-19
- Last updated
- 2005-06-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00004338. Inclusion in this directory is not an endorsement.