Study of Zinc for Wilson Disease

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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

N/A - 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