Zinc Supplementation in Alcoholic Cirrhosis

Completed · Not applicable · Has a placebo group

Conditions studied: Alcoholic Cirrhosis

In brief

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.

Key facts

Study ID

NCT02072746

Run by

University of Louisville

People needed

30

Starts

2010-02-01

Expected to finish

2019-03-01

Last updated by the study team

2021-03-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Louisville — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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