Copper supplementation for people with cirrhosis

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

This trial will try giving copper supplements to adults with cirrhosis who have low copper levels or signs of copper deficiency to see if liver-related health improves.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Washington (other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT07471542 on ClinicalTrials.gov

What this trial studies

This is an interventional trial giving oral copper (copper gluconate) to adults with confirmed cirrhosis who have low serum/plasma copper or clinical features suggestive of copper deficiency. Participants will be treated and followed at the University of Washington Medical Center with serial blood tests and clinical monitoring for liver function, nutritional status, and infection-related outcomes. Patients with conditions associated with copper overload (for example Wilson disease or cholestatic liver diseases) or with fulminant hepatic failure are excluded. The approach is based on prior observational work and small case reports suggesting copper deficiency is common in liver disease and may be reversible with supplementation.

Who should consider this trial

Good fit: Adults aged 18 or older with confirmed cirrhosis who have low serum/plasma copper or normal copper with at least one clinical feature associated with copper deficiency (for example infections, unexplained anemia, severe leukopenia, iron overload, neurologic symptoms, or coagulopathy) are the intended candidates.

Not a fit: Patients with Wilson disease, cholestatic liver diseases (such as primary biliary cholangitis or primary sclerosing cholangitis), fulminant hepatic failure, or those without biochemical or clinical evidence of copper deficiency are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, copper supplementation could improve liver function measures, reduce infection risk, and improve nutritional and clinical outcomes for some people with cirrhosis.

How similar studies have performed: Small case reports and a 2023 observational cohort found copper deficiency is common in liver disease and reported anecdotal improvement after supplementation, but randomized controlled evidence is not yet available.

Eligibility criteria

Inclusion Criteria:

1. Adult patients age 18 or older with confirmed diagnosis of cirrhosis based on clinical history, exam, imaging, laboratory or histological criteria;
2. Cirrhosis patients whose serum or plasma Cu are below the normal range (80-155 ug/dL for women and 70-140 ug/dL for men);
3. Cirrhosis patients whose serum or plasma Cu are in the normal range but exhibit at least one clinical feature that has been associated with Cu deficiency. These include history of infections, unexplained anemia, severe leukopenia, iron overload, unexplained neurological symptoms such as ataxia or myelopathy, coagulopathy with spontaneous bleeding.

Patients must meet inclusion criteria 1 AND 2, or 1 AND 3 in order to be considered for the trial

Exclusion Criteria:

1. Patients with Wilson disease, cholestatic liver diseases including primary biliary cholangitis and primary sclerosing cholangitis, all of which are associated with Cu overload;
2. Patients with fulminant hepatic failure;
3. Renal failure with a creatinine clearance \<25 ml/minute;
4. Hepatic encephalopathy more than grade 2 (Hepatic Encephalopathy in Chronic Liver Disease, 2014);
5. MELD score \>25 to minimize subject dropout due to been too ill;
6. Serious non-liver related medical illnesses such as cardiopulmonary and renal diseases and non-liver malignancies;
7. Active alcohol use;
8. Pregnancy

Where this trial is running

Seattle, Washington

• University of Washington Medical Center — Seattle, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Lei Yu, MD — University of Washington
• Study coordinator: Laura Sissons-Ross

Conditions: Cirrhosis, Chronic Liver Disease, Fibrosis, Infection, copper, cirrhosis, malnutrition