Copper Supplementation for Liver Cirrhosis
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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive either copper supplementation or placebo for the first 6 weeks
Washout
A 3-week washout period between treatment phases
Treatment Period 2
Participants receive the alternate treatment (copper supplementation or placebo) for another 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Placebo first, washout, then copper supplementation
copper supplementation first, washout, then placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Alaska Fairbanks
Collaborator
Citations
1.
trial.medpath.com
trial.medpath.com/clinical-trial/357945eb6265e866/nct07471542-copper-supplementation-cirrhosis-biochemical-safety-outcomesCopper 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 ...
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