Pilot Study of Copper Supplementation Effects on Safety and Biochemical Outcomes in Adults with Cirrhosis

What this Trial Is About

Chronic liver disease, especially cirrhosis, is a leading cause of death worldwide with limited medical treatments that can alter its progression. Malnutrition plays a significant role in worsening cirrhosis outcomes. Copper, an essential trace metal regulated mainly by the liver, has been found deficient in many liver disease patients and linked to severe disease, higher infection rates, and increased mortality. This research investigates whether copper supplementation can improve biochemical changes and patient outcomes in cirrhosis. Participants in this pilot randomized, placebo-controlled, crossover trial will receive oral copper gluconate 4 mg daily or placebo for a 6-week period, followed by a 3-week washout, then switch to the alternate treatment for another 6 weeks. Two groups alternate the order one starts with copper then placebo, and the other starts with placebo then copper. The study evaluates coppers biochemical effects, safety, and patient-reported outcomes during these periods. Throughout the 15-week trial, participants will be monitored at baseline, after each 6-week intervention, and after the washout period. Researchers will measure plasma copper concentrations, biomarkers of copper status, safety indicators, nutritional and functional status, and patient-reported outcomes. This detailed monitoring will assess copper supplementations impact on cirrhosis-related biochemical and clinical changes under careful safety observation.

Copper Supplementation in Cirrhosis