Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07471542

A Pilot Randomized Controlled Trial to Determine the Biochemical Effect, Safety and Patient Reported Outcomes of Copper Supplementation in Patients With Cirrhosis

Led by University of Washington · Updated on 2026-03-13

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Chronic liver disease, especially cirrhosis, is a leading cause of death worldwide with limited medical treatments that can alter its progression. Malnutrition plays a significant role in worsening cirrhosis outcomes. Copper, an essential trace metal regulated mainly by the liver, has been found deficient in many liver disease patients and linked to severe disease, higher infection rates, and increased mortality. This research investigates whether copper supplementation can improve biochemical changes and patient outcomes in cirrhosis. Participants in this pilot randomized, placebo-controlled, crossover trial will receive oral copper gluconate 4 mg daily or placebo for a 6-week period, followed by a 3-week washout, then switch to the alternate treatment for another 6 weeks. Two groups alternate the order: one starts with copper then placebo, and the other starts with placebo then copper. The study evaluates copper's biochemical effects, safety, and patient-reported outcomes during these periods. Throughout the 15-week trial, participants will be monitored at baseline, after each 6-week intervention, and after the washout period. Researchers will measure plasma copper concentrations, biomarkers of copper status, safety indicators, nutritional and functional status, and patient-reported outcomes. This detailed monitoring will assess copper supplementation's impact on cirrhosis-related biochemical and clinical changes under careful safety observation.

CONDITIONS

Brief Title

Copper Supplementation in Cirrhosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients age 18 or older with confirmed diagnosis of cirrhosis based on clinical history, exam, imaging, laboratory or histological criteria
  • Cirrhosis patients whose serum or plasma copper are below the normal range (80-155 ug/dL for women and 70-140 ug/dL for men)
  • Cirrhosis patients with normal serum or plasma copper but at least one clinical feature linked to copper deficiency such as history of infections, unexplained anemia, severe leukopenia, iron overload, unexplained neurological symptoms, or coagulopathy with spontaneous bleeding
  • Patients must meet inclusion criteria 1 AND 2, or 1 AND 3 to be considered for the trial
Not Eligible

You will not qualify if you...

  • Patients with Wilson disease, primary biliary cholangitis, primary sclerosing cholangitis, or other cholestatic liver diseases associated with copper overload
  • Patients with fulminant hepatic failure
  • Patients with renal failure with creatinine clearance less than 25 ml/minute
  • Patients with hepatic encephalopathy more than grade 2
  • Patients with MELD score greater than 25
  • Patients with serious non-liver medical illnesses such as cardiopulmonary, renal diseases, or non-liver cancers
  • Patients with active alcohol use
  • Pregnant patients

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Treatment

Duration - 15 weeks total including two 6-week intervention periods and a 3-week washout period

Participants receive oral copper gluconate 4 mg daily or placebo in a randomized crossover design, with a washout period between treatments.

Visits at randomization, end of first 6-week intervention, end of 3-week washout, and end of second 6-week intervention

Trial Site Locations

Total: 1 location

1

University of Washington Medical Center

Seattle, Washington, United States, 98195

Actively Recruiting

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Research Team

L

Laura Sissons-Ross

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Trace element deficiency is highly prevalent and associated with infection and mortality in patients with alcoholic hepatitis.

Ashwin Dhanda, Stephen Atkinson, Nikhil Vergis...

https://pubmed.ncbi.nlm.nih.gov/32573823