Study of Zinc for Wilson Disease - Article Orazinc; Verazinc; Zinc 15; Zinc Gluconate; Zinc Sulfate; Zincate
Clinical Trial: Study of Zinc for Wilson Disease
This study has been completed.
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||Treatment or Intervention||Phase|
|Wilson Disease || Drug: zinc acetate ||Phase IV |
MedlinePlus related topics: Wilson's Disease
Genetics Home Reference related topics: Wilson disease
Study Type: Interventional
Study Design: Treatment, Safety/Efficacy Study
Expected Total Enrollment: 300
Study start: October 1993
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.
Genders Eligible for Study: Both
University of Michigan Health Systems, Ann Arbor, Michigan, 48109, United States
George J. Brewer, Study Chair, University of Michigan
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: 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.
Record last reviewed: December 2003
Last Updated: October 13, 2004
Record first received: October 18, 1999
ClinicalTrials.gov Identifier: NCT00004338
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005