A Controlled Study of Potential Therapeutic Effect of Oral Zinc in Manifesting Carriers of Wilson Disease

NCT ID: NCT03659331

Last Updated: 2018-09-06

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2019-10-31

Brief Summary

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The assumption is that in some of the carriers, the increase in enzymes reflects tissue damage due to excess copper. The reduction of the amount of copper absorbed will decrease excess copper in the liver, which will result in a decrease in the level of liver enzymes. Zinc causes the induction of metalothionines in the intestine, which in turn prevents absorption of copper from the digestive system. Zinc administration in Wilson's patients causes the depletion of copper deposits and constitutes one of the cornerstones in the treatment of this disease.

Detailed Description

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The research group is composed of patients over the age of 18 referred for unexplained elevation of liver enzymes and carry a single mutation in the ATP7B gene. After a washout period of 3 months these patients will be re-checked for liver enzymes and if high will receive zinc therapy at a dose of 300 mg / day for 6 months, after which the liver enzymes will be checked again.

Conditions

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Wilson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A model based on the assumption that at least 50 subjects will be recruited, and assuming that 50% of the patients will have a significant reduction of liver enzymes
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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unexplained elevation of liver enzymes

patients over the age of 18 referred for unexplained elevation of liver enzymes and carry a single mutation in the ATP7B gene. After a washout period of 3 months these patients will be re-checked for liver enzymes and if high will receive zinc therapy at a dose of 300 mg / day for 6 months, after which the liver enzymes will be checked again.

Group Type EXPERIMENTAL

Zinc

Intervention Type DIETARY_SUPPLEMENT

blood tests will be performed: GGT SGOT, SGPT, LDH, A.P. Direct and indirect bilirubin, blood proteins, cholesterol, P.T. and a complete blood count.

Interventions

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Zinc

blood tests will be performed: GGT SGOT, SGPT, LDH, A.P. Direct and indirect bilirubin, blood proteins, cholesterol, P.T. and a complete blood count.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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blood tests

Eligibility Criteria

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Inclusion Criteria

patients over the age of 18 unexplained elevation of liver enzymes patients that carry a single mutation in the ATP7B gene.

\-

Exclusion Criteria

na
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Elon Pras

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Elon Pras

head of The Institute of Human Genetics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Elon Pras, Prof

Role: PRINCIPAL_INVESTIGATOR

The Institute of Human Genetics, Sheba Medical Center, Israel

Central Contacts

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Elon Pras, Prof

Role: CONTACT

972-35302998

Other Identifiers

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4987-18-SMC

Identifier Type: -

Identifier Source: org_study_id

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