Zinc Supplementation in Alcoholic Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2019-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alcoholic Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zinc

zinc sulfate 220 mg daily

Group Type ACTIVE_COMPARATOR

Zinc

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo study for comparison

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Zinc

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Zinc sulfate 220 mg

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes