Study of Zinc for Wilson Disease
Primary Purpose
Wilson Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
zinc acetate
Sponsored by
About this trial
This is an interventional treatment trial for Wilson Disease focused on measuring Wilson disease, inborn errors of metabolism, rare disease
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: Wilson disease Presymptomatic, pregnant, and children 16 years or younger patients eligible Patient age: Any age, including children
Sites / Locations
- University of Michigan Health Systems
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004338
First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT00004338
Brief Title
Study of Zinc for Wilson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
October 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Michigan
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wilson Disease
Keywords
Wilson disease, inborn errors of metabolism, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
zinc acetate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: Wilson disease Presymptomatic, pregnant, and children 16 years or younger patients eligible Patient age: Any age, including children
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George J. Brewer
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
University of Michigan Health Systems
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
1940587
Citation
Brewer GJ, Yuzbasiyan-Gurkan V, Johnson V. Treatment of Wilson's disease with zinc. IX: Response of serum lipids. J Lab Clin Med. 1991 Nov;118(5):466-70.
Results Reference
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PubMed Identifier
1517684
Citation
Yuzbasiyan-Gurkan V, Grider A, Nostrant T, Cousins RJ, Brewer GJ. Treatment of Wilson's disease with zinc: X. Intestinal metallothionein induction. J Lab Clin Med. 1992 Sep;120(3):380-6.
Results Reference
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PubMed Identifier
8475943
Citation
Brewer GJ, Yuzbasiyan-Gurkan V, Johnson V, Dick RD, Wang Y. Treatment of Wilson's disease with zinc XII: dose regimen requirements. Am J Med Sci. 1993 Apr;305(4):199-202. doi: 10.1097/00000441-199304000-00001.
Results Reference
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PubMed Identifier
8440814
Citation
Brewer GJ, Yuzbasiyan-Gurkan V, Johnson V, Dick RD, Wang Y. Treatment of Wilson's disease with zinc: XI. Interaction with other anticopper agents. J Am Coll Nutr. 1993 Feb;12(1):26-30. doi: 10.1080/07315724.1993.10718278.
Results Reference
background
PubMed Identifier
8201263
Citation
Brewer GJ, Dick RD, Yuzbasiyan-Gurkan V, Johnson V, Wang Y. Treatment of Wilson's disease with zinc. XIII: Therapy with zinc in presymptomatic patients from the time of diagnosis. J Lab Clin Med. 1994 Jun;123(6):849-58.
Results Reference
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PubMed Identifier
9178732
Citation
Brewer GJ, Johnson V, Kaplan J. Treatment of Wilson's disease with zinc: XIV. Studies of the effect of zinc on lymphocyte function. J Lab Clin Med. 1997 Jun;129(6):649-52. doi: 10.1016/s0022-2143(97)90200-6.
Results Reference
background
PubMed Identifier
9227444
Citation
Beck FW, Prasad AS, Kaplan J, Fitzgerald JT, Brewer GJ. Changes in cytokine production and T cell subpopulations in experimentally induced zinc-deficient humans. Am J Physiol. 1997 Jun;272(6 Pt 1):E1002-7. doi: 10.1152/ajpendo.1997.272.6.E1002.
Results Reference
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Study of Zinc for Wilson Disease
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