University of Louisville
Louisville, Kentucky, 40202, United States
NCT Number: NCT02072746
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Louisville, Kentucky, 40202, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Zinc sulfate 220 mg
Time frame: Baseline to 3 months
Whether the subject has improved clinically at time point.
Time frame: 0,3,6,12,24 months
Time frame: 0,3,6,12,24 months
Whether the subject has a change in the serum endotoxin levels.
University of Louisville
Other
A Double-Blind, Randomized, Placebo-Controlled Study of the Effects of Daily Oral Zinc Sulfate (220 mg) in Subjects With Alcoholic Cirrhosis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02326103
Alcohol-Induced Disorders, Alcohol-Related Disorders
Helsinki, Finland
View Trial DetailsNCT00388323
Alcohol-Induced Disorders, Alcohol-Related Disorders
Clamart, France
View Trial DetailsNCT06866496
Alcohol-Induced Disorders, Alcohol-Related Disorders
Hvidovre, Capital Region, Denmark
View Trial DetailsNCT01756794
Alcohol-Induced Disorders, Alcohol-Related Disorders
Antwerp, Edegem, Belgium
View Trial Details