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Zinc Supplementation in Alcoholic Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02072746
Recruitment Status : Active, not recruiting
First Posted : February 27, 2014
Last Update Posted : August 7, 2017
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Matthew Cave, University of Louisville

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2010
Actual Primary Completion Date : March 1, 2011
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Active Comparator: Zinc
zinc sulfate 220 mg daily
Dietary Supplement: Zinc
Other Name: Zinc sulfate 220 mg

Placebo Comparator: Placebo
Placebo study for comparison
Dietary Supplement: Placebo

Primary Outcome Measures :
  1. Change in clinical status [ Time Frame: Baseline to 3 months ]
    Whether the subject has improved clinically at time point.

Secondary Outcome Measures :
  1. Blood zinc levels [ Time Frame: 0,3,6,12,24 months ]
  2. Change in serum endotoxin levels [ Time Frame: 0,3,6,12,24 months ]
    Whether the subject has a change in the serum endotoxin levels.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02072746

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United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Principal Investigator: Matthew Cave, MD University of Louisville

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Responsible Party: Matthew Cave, Associate Professor, University of Louisville Identifier: NCT02072746     History of Changes
Other Study ID Numbers: OICB10007
K23AA018399 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017

Keywords provided by Matthew Cave, University of Louisville:

Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Cirrhosis, Alcoholic
Pathologic Processes
Liver Diseases
Digestive System Diseases
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Zinc Sulfate
Trace Elements
Growth Substances
Physiological Effects of Drugs
Dermatologic Agents