Clinical Trial: Zinc Supplementation in Alcoholic Cirrhosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Double-Blind, Randomized, Placebo-Controlled Study of the Effects of Daily Oral Zinc Sulfate (220 mg) in Subjects With Alcoholic Cirrhosis

Brief Summary: The purpose of this study is to determine if zinc therapy: (1) strengthens your intestine's defensive barrier preventing damaging substances from reaching your liver, (2) decreases liver injury (inflammation, oxidative stress, cell death) and scarring, and (3) improves your liver-related health. Based on our preliminary animal data and other published reports, we expect zinc therapy to achieve all of these goals. Zinc is affordable, available over the counter or by prescription, and has an excellent safety profile. Positive results from this study will show that zinc is a significant therapy for millions of Americans with alcoholic liver disease.

Detailed Summary: Two-thirds of Americans consume alcohol, and an estimated 14 million Americans are alcoholics. It has been estimated that 15%-30% of heavy drinkers develop advanced Alcoholic liver disease (ALD). The prevalence of ALD in the United States is conservatively estimated at 2 million persons. Nearly 50% of liver-related deaths and 30% of hepatocellular carcinomas in the US are due to alcoholic cirrhosis. Despite recent advances in our understanding of ALD, there is currently no FDA approved medication for any stage of ALD. Zinc sulfate is inexpensive, available over the counter, and has an excellent safety profile. If zinc positively influences the mechanisms postulated to play a role in human ALD, this affordable treatment would become relevant to millions of people worldwide.
Sponsor: University of Louisville

Current Primary Outcome: Change in clinical status [ Time Frame: Baseline to 3 months ]

Whether the subject has improved clinically at time point.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Blood zinc levels [ Time Frame: 0,3,6,12,24 months ]
  • Change in serum endotoxin levels [ Time Frame: 0,3,6,12,24 months ]
    Whether the subject has a change in the serum endotoxin levels.


Original Secondary Outcome: Same as current

Information By: University of Louisville

Dates:
Date Received: February 19, 2014
Date Started: February 2013
Date Completion: March 2018
Last Updated: May 10, 2016
Last Verified: May 2016