We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Zinc for Wilson Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004338
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
University of Michigan
Information provided by:
National Center for Research Resources (NCRR)

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.


Condition or disease Intervention/treatment Phase
Wilson Disease Drug: zinc acetate Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Primary Purpose: Treatment
Study Start Date : October 1993

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Wilson Disease
U.S. FDA Resources





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
PROTOCOL ENTRY CRITERIA: Wilson disease Presymptomatic, pregnant, and children 16 years or younger patients eligible Patient age: Any age, including children

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004338


Locations
United States, Michigan
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Michigan
Investigators
Study Chair: George J. Brewer University of Michigan

Publications:
ClinicalTrials.gov Identifier: NCT00004338     History of Changes
Other Study ID Numbers: 199/11897
UMMC-310
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003

Keywords provided by National Center for Research Resources (NCRR):
Wilson disease
inborn errors of metabolism
rare disease

Additional relevant MeSH terms:
Hepatolenticular Degeneration
Liver Diseases
Digestive System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Metal Metabolism, Inborn Errors
Metabolic Diseases