Zinc Supplementation as Treatment of Dysgeusias in Cirrhotic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Dysgeusia
研究概览
简要总结
The purpose of this study is to evaluate the effect of zinc supplementation in the treatment for dysgeusia, progression disease and quality of life in patients with liver cirrhosis.
详细描述
Taste disorders are symptomatologies in patients with cirrhosis, these have a direct effect in modification of food consumption, increasing weight loss, anorexia and malnutrition, which impacts in decompensation rates and mortality.
It has been proposed that zinc deficiency is one of the causes for development of taste disorders. The aim of this study is to describe the presence of taste disorders in patients with cirrhosis and evaluate the effect of zinc supplementation in treatment of taste disorders, and in progression of chronic liver disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhotic patients by any etiology, with any dysgeusia
排除标准
- •Patients with hepatic encephalopathy at the time of dysgeusia evaluation
- •Patients with any neurological disease
- •Patients with respiratory diseases ath the time of dysgeusia evaluation
- •Patients with active alcohol consumption
研究组 & 干预措施
100 mg placebo
100 mg Placebo plus nutritional education
干预措施: Placebo (Dietary Supplement)
100 mg placebo
100 mg Placebo plus nutritional education
干预措施: Nutritional education (Behavioral)
100 mg zinc supplement
Nutritional education plus 100 mg of zinc gluconate
干预措施: Nutritional education (Behavioral)
100 mg zinc supplement
Nutritional education plus 100 mg of zinc gluconate
干预措施: zinc gluconate (Dietary Supplement)
结局指标
主要结局
Dysgeusia
时间窗: Presence of any taste disorder at 6 months
Evaluation of presence of any taste disorder, according to questionnaires and evaluation of perception and recognition thresholds with ascending molar concentrations of basic tastes.
次要结局
未报告次要终点
研究者
Norberto Carlos Chavez Taia
Obesity and Digestive Diseases Unit Chief
Fundación Clínica Médica Sur