Zinc Supplementation in Alcoholic Cirrhosis

NCT02072746 | Completed

• 2 other identifiers: OICB10007K23AA018399
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholic Cirrhosis

Keywords

cirrhosis; alcohol

Outcome Measures

Primary Outcomes (1)

• Change in clinical status

  Whether the subject has improved clinically at time point.

  Baseline to 3 months

Secondary Outcomes (2)

• Blood zinc levels

  0,3,6,12,24 months

• Change in serum endotoxin levels

  0,3,6,12,24 months

Study Arms (2)

Zinc

ACTIVE COMPARATOR

zinc sulfate 220 mg daily

Dietary Supplement: Zinc

Placebo

PLACEBO COMPARATOR

Placebo study for comparison

Dietary Supplement: Placebo

Interventions

Zinc DIETARY_SUPPLEMENT

Also known as: Zinc sulfate 220 mg

Zinc

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Louisville: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic; Fibrosis

Interventions

Zinc; Zinc Sulfate

Condition Hierarchy (Ancestors)

Liver Cirrhosis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Zinc Compounds

Study Officials

• Matthew Cave, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 27, 2014
• Study Start: February 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2019
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

US (1)