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

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Brief Title

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

Official Title

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

Brief Summary

      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

      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.
    


Study Type

Interventional


Primary Outcome

measurement of liver enzymes in blood tests


Condition

Wilson Disease

Intervention

Zinc

Study Arms / Comparison Groups

 unexplained elevation of liver enzymes
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

50

Start Date

September 2018

Completion Date

October 2019

Primary Completion Date

August 2019

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Elon Pras, Prof, 972-35302998, [email protected]



Administrative Informations


NCT ID

NCT03659331

Organization ID

4987-18-SMC


Responsible Party

Sponsor-Investigator

Study Sponsor

Prof. Elon Pras


Study Sponsor

Elon Pras, Prof, Principal Investigator, The Institute of Human Genetics, Sheba Medical Center, Israel


Verification Date

September 2018