Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
300 participants
INTERVENTIONAL
1993-10-31
Brief Summary
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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
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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zinc acetate
Eligibility Criteria
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Inclusion Criteria
0 Years
ALL
No
Sponsors
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University of Michigan
OTHER
National Center for Research Resources (NCRR)
NIH
Principal Investigators
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George J. Brewer
Role: STUDY_CHAIR
University of Michigan
Locations
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University of Michigan Health Systems
Ann Arbor, Michigan, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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UMMC-310
Identifier Type: -
Identifier Source: secondary_id
199/11897
Identifier Type: -
Identifier Source: org_study_id