Zinc Supplementation in Alcoholic Cirrhosis

Alcoholic Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072746
• Other study ID #: OICB10007
• Secondary ID: K23AA018399
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2021
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholic Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Liver Cirrhosis, Alcoholic

Intervention

Dietary Supplement:
• Zinc

• Placebo

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinical status	Whether the subject has improved clinically at time point.	Baseline to 3 months
Secondary	Blood zinc levels		0,3,6,12,24 months
Secondary	Change in serum endotoxin levels	Whether the subject has a change in the serum endotoxin levels.	0,3,6,12,24 months