Zinc Supplementation in Alcoholic Cirrhosis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 5/12/2016 |
| Start Date: | February 2013 |
| End Date: | March 2018 |
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.
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.
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.
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.
We found this trial at
1
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University of Louisville The University of Louisville is a state supported research university located in...
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