Overview

This trial is active, not recruiting.

Condition alcoholic cirrhosis
Treatments zinc, placebo
Sponsor University of Louisville
Collaborator National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date February 2013
End date March 2018
Trial size 30 participants
Trial identifier NCT02072746, K23AA018399, OICB10007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
zinc sulfate 220 mg daily
zinc Zinc sulfate 220 mg
(Placebo Comparator)
Placebo study for comparison
placebo

Primary Outcomes

Measure
Change in clinical status
time frame: Baseline to 3 months

Secondary Outcomes

Measure
Blood zinc levels
time frame: 0,3,6,12,24 months
Change in serum endotoxin levels
time frame: 0,3,6,12,24 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: 1. Ability to provide informed consent. 2. Clinical diagnosis of alcoholic cirrhosis. 3. Between the ages of 18 years and 70 years. 4. Ability to attend all clinic visits and participate in monthly telephone calls. 5. Child-Pugh score of A or B. Exclusion Criteria: 1. Allergy or intolerance to zinc sulfate. 2. Hospitalization within the previous 28 days. 3. Pregnancy. 4. Illicit drug use within the past 12 months. 5. Infection with hepatitis B, hepatitis C, or HIV. 6. Known or suspected cancer within the past 5 years. 7. Serum creatinine greater than 1.5 mg/dl within the past month. 8. Any severe chronic disease other than liver disease. 9. Impairment (slowness) of behavior, intelligence, and neuromuscular function which may indicate hepatic encephalopathy (slow or confused thinking due to your liver disease). 10. Participation in another clinical trial. 11. Any type of infection within the past month.

Additional Information

Official title A Double-Blind, Randomized, Placebo-Controlled Study of the Effects of Daily Oral Zinc Sulfate (220 mg) in Subjects With Alcoholic Cirrhosis
Principal investigator Matthew Cave, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Louisville.