Study of Zinc for Wilson Disease - Full Text View

Purpose

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	Intervention	Phase
Wilson Disease	Drug: zinc acetate	Phase IV

Genetics Home Reference related topics:

familial encephalopathy with neuroserpin inclusion bodies Wilson disease

MedlinePlus related topics:

Wilson Disease

ChemIDplus related topics:

Zinc acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety/Efficacy Study

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:	300
Study Start Date:	October 1993

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

Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

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.

Study ID Numbers:	199/11897, UMMC-310
First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004338
Health Authority:	United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):

Wilson disease

inborn errors of metabolism

rare disease

Study placed in the following topic categories:

Wilson disease

Liver Diseases

Metabolic Diseases

Ganglion Cysts

Hepatolenticular Degeneration

Basal Ganglia Diseases

Rare Diseases

Central Nervous System Diseases

Neurodegenerative Diseases

Brain Diseases

Metabolism, Inborn Errors

Digestive System Diseases

Heredodegenerative Disorders, Nervous System

Genetic Diseases, Inborn

Movement Disorders

Zinc

Brain Diseases, Metabolic, Inborn

Metabolic disorder

Brain Diseases, Metabolic

Additional relevant MeSH terms:

Nervous System Diseases

Metal Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on August 28, 2008

Sponsors and Collaborators:	National Center for Research Resources (NCRR) University of Michigan
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00004338