Brief Title
Study of Zinc for Wilson Disease
Brief 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.
Study Phase
Phase 4
Study Type
Interventional
Condition
Wilson Disease
Intervention
zinc acetate
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
300
Start Date
October 1993
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: Wilson disease Presymptomatic, pregnant, and children 16 years or
younger patients eligible Patient age: Any age, including children
Gender
All
Ages
0 Years - N/A
Accepts Healthy Volunteers
No
Contacts
George J. Brewer, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00004338
Organization ID
199/11897
Secondary IDs
UMMC-310
Study Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Michigan
Study Sponsor
George J. Brewer, Study Chair, University of Michigan
Verification Date
December 2003