Copper Supplementation in Cirrhosis

What Was Tested

The trial (not phased) is built around Copper (Supplement).

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.

It had two arms (groups): Copper supplementation 1st arm (experimental) and Placebo first arm (experimental).

Copper supplementation first, washout, then placebo.

Placebo first, washout, then copper supplementation.

The registry classes the interventions as dietary supplement.

More on the Plan

Approximately 41,000 people die annually of chronic liver disease (CLD) including liver cancer in the United States.

The annual cost of care for patients with cirrhosis, the most advanced stage of liver disease, is approximately $21 billion.

While liver transplantation is a curative, albeit costly, treatment, there are far fewer donors than patients in need of liver transplants.

Other than targeting the causes of cirrhosis, such as alcohol cessation and antiviral therapy, very few medical treatments can change the natural history of cirrhosis.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult patients age 18 or older with confirmed diagnosis of cirrhosis based on clinical history, exam, imaging, laboratory or histological criteria;.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: patients with fulminant hepatic failure;; hepatic encephalopathy more than grade 2 (hepatic encephalopathy in chronic liver disease, 2014);; MELD score \>25 to minimize subject dropout due to been too ill;.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

Because people in this Copper (Supplement) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Copper (Supplement) and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Copper (Supplement).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-03-15 with completion listed for 2028-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Plasma copper (Cu) concentration.

It also tracked 14 secondary outcomes, for example Biomarkers of functional Copper (Cu) status, Biomarkers of functional copper status, Biomarker of functional copper status, Biomarker of functional copper status, Biomarker of functional copper status and Safety measures.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Copper (Supplement) in 30 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Copper (Supplement) compound page, all human trials.