Clinical trial NCT02072746: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholic Cirrhosis
Keywords: cirrhosis
alcohol
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2014-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in clinical status
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Blood zinc levels
timeFrame: 0,3,6,12,24 months
measure: Change in serum endotoxin levels
timeFrame: 0,3,6,12,24 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Matthew Cave, MD
role: PRINCIPAL_INVESTIGATOR
References: