A Double-Blind, Randomized, Placebo-Controlled Study of the Effects of Daily Oral Zinc Sulfate (220 mg) in Subjects With Alcoholic Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in clinical status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Allergy or intolerance to zinc sulfate.
- •Hospitalization within the previous 28 days.
- •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.
结局指标
主要结局
Change in clinical status
时间窗: Baseline to 3 months
Whether the subject has improved clinically at time point.
次要结局
- Blood zinc levels(0,3,6,12,24 months)
- Change in serum endotoxin levels(0,3,6,12,24 months)
研究者
Matthew Cave
Associate Professor
University of Louisville