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Study of Zinc for Wilson Disease



Study of Zinc for Wilson Disease

For Condition: Wilson Disease
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , University of Michigan
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: Wilson disease Presymptomatic, pregnant, and children 16 years or younger patients eligible Patient age: Any age, including children
Total Enrollment: 300

Location and Contact Information:

Overall Study Official:
GeorgeBrewer,  Study Chair,  University of Michigan

University of Michigan Health Systems
Ann Arbor,  Michigan,  48109
United States
 


Additional Information:
Study ID Numbers:
  199/11897;  UMMC-310
Study Start Date: October 1993
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004338

Other Wilson Disease Studies:
1. Study of Zinc for Wilson Disease

2. Study of Tetrathiomolybdate in Patients With Wilson Disease

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