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Zinc Supplementation in Alcoholic Cirrhosis

Primary Purpose

Alcoholic Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zinc
Placebo
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholic Cirrhosis focused on measuring cirrhosis, alcohol

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Louisville

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Zinc

Placebo

Arm Description

zinc sulfate 220 mg daily

Placebo study for comparison

Outcomes

Primary Outcome Measures

Change in clinical status
Whether the subject has improved clinically at time point.

Secondary Outcome Measures

Blood zinc levels
Change in serum endotoxin levels
Whether the subject has a change in the serum endotoxin levels.

Full Information

First Posted
February 19, 2014
Last Updated
March 17, 2021
Sponsor
University of Louisville
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02072746
Brief Title
Zinc Supplementation in Alcoholic Cirrhosis
Official Title
A Double-Blind, Randomized, Placebo-Controlled Study of the Effects of Daily Oral Zinc Sulfate (220 mg) in Subjects With Alcoholic Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 2010 (Actual)
Primary Completion Date
March 1, 2011 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Cirrhosis
Keywords
cirrhosis, alcohol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zinc
Arm Type
Active Comparator
Arm Description
zinc sulfate 220 mg daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo study for comparison
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc
Other Intervention Name(s)
Zinc sulfate 220 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in clinical status
Description
Whether the subject has improved clinically at time point.
Time Frame
Baseline to 3 months
Secondary Outcome Measure Information:
Title
Blood zinc levels
Time Frame
0,3,6,12,24 months
Title
Change in serum endotoxin levels
Description
Whether the subject has a change in the serum endotoxin levels.
Time Frame
0,3,6,12,24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Cave, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Zinc Supplementation in Alcoholic Cirrhosis

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