30 Participants NeededMy employer runs this trial

Copper Supplementation for Liver Cirrhosis

LS
Overseen ByLaura Sissons-Ross
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Washington
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if copper supplements, specifically Copper Gluconate, can improve liver function in individuals with cirrhosis, a serious liver condition. Researchers seek to discover whether adding copper can reduce the risk of infections and other health issues often associated with low copper levels in these patients. Participants will receive either a copper supplement or a placebo (a harmless pill resembling the supplement), with a switch after a break. Individuals diagnosed with cirrhosis and experiencing low copper levels or specific health issues related to copper deficiency may be suitable for this trial.

As an unphased trial, this study provides a unique opportunity for participants to contribute to significant research that could lead to new insights and potential treatments for liver conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that copper supplements improved liver function in 2 out of 3 patients with liver problems. This finding suggests that copper might benefit liver health. Copper gluconate, the form used in these supplements, is generally considered safe for food and dietary supplements. However, avoid taking copper with high doses of zinc, as zinc can hinder copper absorption. Overall, current research indicates that copper supplements are likely safe to use.12345

Why are researchers excited about this trial?

Researchers are excited about using copper gluconate for liver cirrhosis because it introduces a novel approach by potentially addressing copper deficiency, which is thought to play a role in liver health. Unlike traditional treatments that may focus on managing symptoms or complications, copper supplementation aims to tackle an underlying nutritional aspect by replenishing essential minerals. This could lead to improved liver function and overall health outcomes for patients with cirrhosis, offering a fresh perspective compared to standard treatments like lifestyle changes, medications to manage complications, or liver transplants.

What evidence suggests that copper supplementation might be an effective treatment for liver cirrhosis?

Research has shown that copper supplements might improve liver function in people with cirrhosis. In one study, 2 out of 3 patients who took copper supplements experienced better liver function. Another study found that cirrhosis patients with low copper levels had twice the rate of infections and three times the risk of death. Copper plays a crucial role in health, and the liver helps regulate its levels in the body. This trial will compare two treatment arms: one where participants receive copper supplementation first, followed by a washout period and then placebo, and another where participants receive placebo first, followed by a washout period and then copper supplementation. These findings suggest that correcting low copper levels could benefit people with cirrhosis.23456

Who Is on the Research Team?

LY

Lei Yu, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults (18+) with diagnosed cirrhosis. They can join if their blood copper levels are low, or if they have normal copper but show signs linked to deficiency like frequent infections, unexplained anemia, very low white blood cells, iron overload, nerve problems, or bleeding issues.

Inclusion Criteria

Patients must meet inclusion criteria 1 AND 2, or 1 AND 3 in order to be considered for the trial
I am 18 or older and have been diagnosed with cirrhosis.
I have cirrhosis and low copper levels in my blood.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive either copper supplementation or placebo for the first 6 weeks

6 weeks
Regular visits for monitoring

Washout

A 3-week washout period between treatment phases

3 weeks

Treatment Period 2

Participants receive the alternate treatment (copper supplementation or placebo) for another 6 weeks

6 weeks
Regular visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Copper Gluconate

Trial Overview

The study tests whether taking copper gluconate supplements helps people with cirrhosis by improving copper-related body functions and overall health. Participants will randomly receive either the supplement or a placebo in different periods of the trial.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Placebo first armExperimental Treatment1 Intervention
Group II: Copper supplementation 1st armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

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

Collaborator

Trials
2,513
Recruited
4,366,000+

University of Alaska Fairbanks

Collaborator

Trials
10
Recruited
14,100+

Citations

Copper Supplementation in Cirrhosis | Clinical Trial - MedPath

Improvement in liver function was observed in 2 of the 3 patients who received Cu supplementation. In 2023, the investigators conducted a ...

Copper Supplementation in Cirrhosis

Improvement in liver function was observed in 2 of the 3 patients who received Cu supplementation. In 2023, the investigators conducted a longitudinal cohort ...

Copper Deficiency in Liver Diseases: A Case Series ... - PMC

In 2 of the 3 patients who received copper supplementation, there was an improvement in serum copper, ceruloplasmin, and liver function parameters. Conclusion: ...

Copper Supplementation in Cirrhosis | NCT07471542

Improvement in liver function was observed in 2 of the 3 patients who received Cu supplementation. In 2023, the investigators conducted a longitudinal cohort ...

copper gluconate

Nutritional Deficiency Outcomes: In non-oncological settings, clinical data clearly support the efficacy of copper gluconate in correcting ...

Project Details

Our recent large cohort study identified Cu deficient cirrhosis patients, as defined by low serum Cu concentrations, had higher infection rates and a 3.4-fold ...