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Study of Zinc for Wilson Disease

Information source: National Center for Research Resources (NCRR)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Wilson Disease

Intervention: zinc acetate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: National Center for Research Resources (NCRR)

Official(s) and/or principal investigator(s):
George J. Brewer, Study Chair, Affiliation: University of Michigan

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.

Clinical Details

Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

PROTOCOL ENTRY CRITERIA: Wilson disease Presymptomatic, pregnant, and children 16 years or younger patients eligible Patient age: Any age, including children

Locations and Contacts

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

Related publications:

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.

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.

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.

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.

Starting date: October 1993
Last updated: June 23, 2005

Page last updated: August 20, 2015

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