Copper Supplementation in Cirrhosis

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT07471542
Status
Recruiting
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Conditions

  • Chronic Liver Disease
  • Cirrhosis
  • Fibrosis
  • Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Copper Gluconate — DIETARY_SUPPLEMENT
    Oral copper gluconate 4 mg daily

Study Details

End stage liver disease or cirrhosis is a major cause of mortality in the United States and the world. Other than targeting the underlying cause, such as alcohol cessation and antiviral therapy, very few medical treatments can change the natural history of cirrhosis. Malnutrition is one of the few potentially modifiable factors that have been associated with cirrhosis severity and poor prognosis. The transition metal copper (Cu) is an essential trace metal that must be acquired from diet. Its metabolism is primarily regulated by the liver in its role as a master regulator of nutrients. In 2019, the investigators reported that Cu deficiency defined by below normal serum or liver concentrations occurred in a wide range of liver disorders and was associated with a severe disease phenotype. Improvement in liver function was observed in 2 of the 3 patients who received Cu supplementation. In 2023, the investigators conducted a longitudinal cohort study utilizing clinical, serum and liver explant tissue data from 183 cirrhosis patients. The investigators showed that Cu deficiency was associated with 2-fold higher infection rate and a more than 3-fold increase in the risk of death compared to patients with normal Cu status. These preliminary findings and the well-established importance of Cu in human health prompted the investigators to design the current pilot randomized, placebo-controlled, crossover trial to determine the effect of Cu supplementation on Cu dependent biochemical changes, patient safety and patient reported outcomes in cirrhosis.

Key Dates

Start date
Mar 15, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Copper supplementation 1st arm
    copper supplementation first, washout, then placebo
  • Experimental: Placebo first arm
    Placebo first, washout, then copper supplementation

Primary Outcome Measure

Plasma copper (Cu) concentration [ Time Frame: From randomization to 1. end 6-week; 2. end of 9-week; 3. end of 15 week. First 6 week is intervention period 1 (either copper or placebo); followed by a 3-week washout period; followed by another 6-week intervention period (either placebo or copper). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington Medical CenterSeattleWashington98195
Shukriyah Samoun, BS
[email protected]
2065433220
Lei Yu, MD (PRINCIPAL_INVESTIGATOR)

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By research site
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