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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.
ClinicalTrials.gov Identifier: NCT02072746
Recruitment Status : Active, not recruiting
First Posted : February 27, 2014
Last Update Posted : August 7, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

February 19, 2014
February 27, 2014
August 7, 2017
February 2010
March 1, 2011   (Final data collection date for primary outcome measure)
Change in clinical status [ Time Frame: Baseline to 3 months ]
Whether the subject has improved clinically at time point.
Same as current
Complete list of historical versions of study NCT02072746 on ClinicalTrials.gov Archive Site
  • Blood zinc levels [ Time Frame: 0,3,6,12,24 months ]
  • Change in serum endotoxin levels [ Time Frame: 0,3,6,12,24 months ]
    Whether the subject has a change in the serum endotoxin levels.
Same as current
Not Provided
Not Provided
 
Zinc Supplementation in Alcoholic Cirrhosis
A Double-Blind, Randomized, Placebo-Controlled Study of the Effects of Daily Oral Zinc Sulfate (220 mg) in Subjects With Alcoholic Cirrhosis
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Alcoholic Cirrhosis
  • Dietary Supplement: Zinc
    Other Name: Zinc sulfate 220 mg
  • Dietary Supplement: Placebo
  • Active Comparator: Zinc
    zinc sulfate 220 mg daily
    Intervention: Dietary Supplement: Zinc
  • Placebo Comparator: Placebo
    Placebo study for comparison
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
March 2018
March 1, 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02072746
OICB10007
K23AA018399 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Matthew Cave, University of Louisville
University of Louisville
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Matthew Cave, MD University of Louisville
University of Louisville
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP