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โ† Trials
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Copper Supplementation in Cirrhosis

RecruitingNAAges 18 Years - anyAllUniversity of Washington
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Copper Gluconate
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Where

1 site
University of Washington Medical Center
Seattle, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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