Zinc Supplementation in Alcoholic Cirrhosis

March 17, 2021 updated by: Matthew Cave, University of Louisville

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Zinc
zinc sulfate 220 mg daily
Dietary supplement: Zinc
Other Names:
  • Zinc sulfate 220 mg
Placebo Comparator: Placebo
Placebo study for comparison
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clinical status
Time Frame: Baseline to 3 months
Whether the subject has improved clinically at time point.
Baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood zinc levels
Time Frame: 0,3,6,12,24 months
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.
0,3,6,12,24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Matthew Cave, MD, University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

February 19, 2014

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimate)

February 27, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OICB10007
  • K23AA018399 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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