Skip to main content
OpenTrials
Completed

NCT Number: NCT02072746

Zinc Supplementation in Alcoholic Cirrhosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide informed consent.
  • Clinical diagnosis of alcoholic cirrhosis.
  • Between the ages of 18 years and 70 years.
  • Ability to attend all clinic visits and participate in monthly telephone calls.
  • Child-Pugh score of A or B.

Exclusion criteria

  • Allergy or intolerance to zinc sulfate.
  • Hospitalization within the previous 28 days.
  • Pregnancy.
  • Illicit drug use within the past 12 months.
  • Infection with hepatitis B, hepatitis C, or HIV.
  • Known or suspected cancer within the past 5 years.
  • Serum creatinine greater than 1.5 mg/dl within the past month.
  • Any severe chronic disease other than liver disease.
  • Impairment (slowness) of behavior, intelligence, and neuromuscular function which may indicate hepatic encephalopathy (slow or confused thinking due to your liver disease).
  • Participation in another clinical trial.
  • Any type of infection within the past month.

Treatment and study plan

Zinc

Dietary Supplement

Other names: Zinc sulfate 220 mg

Placebo

Dietary Supplement

Primary outcomes

  1. Change in clinical status

    Time frame: Baseline to 3 months

    Whether the subject has improved clinically at time point.

Secondary outcomes

  1. Blood zinc levels

    Time frame: 0,3,6,12,24 months

  2. Change in serum endotoxin levels

    Time frame: 0,3,6,12,24 months

    Whether the subject has a change in the serum endotoxin levels.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2019
First posted
Feb 27, 2014
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.