Zinc supplementation to improve prognosis in patients with compensated advanced chronic liver disease: a multicenter, randomized, double-blind, placebo-controlled clinical trial

Abstract

Suplementación; Pronóstico; Enfermedad hepática crónica

Supplementation; Prognosis; Chronic liver disease

Suplements; Pronòstic; Malaltia hepàtica crònica

Zinc homeostasis could play a role in compensated advanced chronic liver disease, and its supplementation has been linked to improvement in liver function, a decrease of hepatic complications, and reduction in HCC incidence. Compensated advanced chronic liver disease encompasses a heterogeneous group of patients with variable risks of clinically significant portal hypertension and clinical events. The ANTICIPATE model is a validated model for stratifying these risks. Our aim is to demonstrate that zinc administration can reduce the rate and risk of presenting clinical events (first decompensation, HCC, death, and liver transplantation). This study protocol describes an ongoing phase III, national, multicenter, randomized, double-blind clinical trial that will enroll 300 patients to receive either the trial treatment (zinc acexamate) or placebo. An inclusion period of 42 months is planned, with a minimum follow-up of 2 years. Our principal hypothesis is that zinc could modify the natural history of patients with compensated advanced chronic liver disease, with an overall improvement in prognosis.

Joan Genescà was partially funded by grant PI21/00691 from Instituto de Salud Carlos III and co-funded by the European Regional Development Fund/European Social Fund (ERDF/ESF, “A way to make Europe/Investing in your future”). Mònica Pons is funded by a grant contract, Joan Rodés from the Instituto de Salud Carlos III. CIBERehd is supported by Instituto de Salud Carlos III.