Zinc Supplementation in Alcoholic Cirrhosis

Sponsor

University of Louisville (Other)

Overall Status

Completed

CT.gov ID

NCT02072746

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

Enrollment

Location

Arms

108.9

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholic Cirrhosis	Dietary Supplement: Zinc Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in clinical status [Baseline to 3 months]
Whether the subject has improved clinically at time point.

Secondary Outcome Measures

Blood zinc levels [0,3,6,12,24 months]
Change in serum endotoxin levels [0,3,6,12,24 months]
Whether the subject has a change in the serum endotoxin levels.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.