Clinical trial NCT00004338: Study of Zinc for Wilson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wilson Disease
Keywords: Wilson disease
inborn errors of metabolism
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of Michigan
First posted: 1999-10-19
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
Study officials:
affiliation: University of Michigan
name: George J. Brewer
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.