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

Wilson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03659331
• Other study ID #: 4987-18-SMC
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2018
• Est. completion date: October 2019

Study information

• Verified date: September 2018
• Source: Sheba Medical Center
• Contact: Elon Pras, Prof
• Phone: 972-35302998
• Email: elon.prasProf[@]sheba.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Wilson Disease

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Elon Pras

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of liver enzymes in blood tests	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, is statistically significant and supports the association between a single mutation in the ATP7B gene and liver injury.	9 months