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临床试验/NCT02520817
NCT02520817已完成不适用

Professor of Tropical Medicine

Mansoura University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Serum ammonia levels

研究概览

简要总结

Minimal hepatic encephalopathy (MHE) can have a far-reaching impact on quality and ability to function in daily life and may progress to overt Hepatic Encephalopathy. Patients with MHE were missed in clinical follow up and are more exposure to work accident. The aim of the present study was to assess the effects of oral supplementation of antioxidant and zinc gluconate Versus Lactulose inTruck driver cirrhotic patients with MHE.

详细描述

The aim of the present study was to assess the effects of oral supplementation of antioxidant and zinc gluconate in patients with MHE. Zinc, may be considered as a cofactor of urea cycle enzymes, that deficient in cirrhotic patients; especially if associated, with malnutrition or encephalopathy . Zinc is essential for the synthesis of coenzymes that mediate biogenic amine synthesis and metabolism. Data from studies sustain that, there is a synergistic combined effect between systemic oxidative stress, and ammonia that is implicated in the pathogenesis of hepatic encephalopathy, so that the present study was designed to assess the effects of oral supplementation of antioxidant and zinc gluconate in cirrhotic Truck drivers patients with MHE.

A prospective randomized controlled study comparing the effect of zinc and antioxidant supplementation plus lactulose on MHE versus lactulose alone. Patients who were diagnosed as having MHE were randomly assigned either to receive zinc and antioxidant plus lactulose (group A) or lactulose alone (group B, the control). Patients in group A received 175 mg zinc gluconate, 50000 iu vitamin A, 500 mg vitamin C and 100 mg vitamin E once daily plus lactulose (30-60 ml in 2 or 3 divided doses), while patients in group B received 30-60 ml lactulose in 2 or 3 divided doses so that the patient passed 2-3 semi soft stools per day. The therapy was taken daily for 3 months or until the patients discontinued the study drugs for any reason (e.g. non compliance). All patients were followed up every month for treatment compliance and for development of any complications. The compliance with the therapy was assured primarily by ensuring increased stool frequency and a change to a softer consistency and by counting the number of bottles of lactulose consumed. None of the study, patients were specifically treated by other therapy for MHE within the study period (e.g. rifaximin).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Truck drivers with liver cirrhosis and minimal hepatic encephalopathy.
  • Exclusion criteria:
  • Overt hepatic encephalopathy.
  • Sensory or motor deficits; neurological causes of impaired cognition
  • Electrolyte imbalances (serum sodium level <125 mmol/L; serum calcium level >10 mg per /DL and potassium level <2.5 mmol/L)
  • Ongoing systemic illnesses, intercurrent infection or active spontaneous bacterial peritonitis.
  • Recent history (< 6 weeks) of alcohol intake.
  • Patients on drugs affecting psychometric performances.
  • Recent (<6 weeks) intake of antibiotics for gastrointestinal bleeding, history of shunt operation or trans jugular intrahepatic portosystemic shunt for portal hypertension.
  • Chronic renal impairment (creatinine level >2.0 mg per/ DL.
  • Patients with color blindness, mature cataract and diabetic retinopathy,
  • Hepatocellular carcinoma, or other comorbidities such as congestive heart failure and pulmonary disease.

排除标准

  • 未提供

结局指标

主要结局

Serum ammonia levels

时间窗: 3 months

Neuropsychometric tests including number connection test-part A, digit symbol test and block-design test.

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nasser Mousa

Professor of Tropical Medicine

Mansoura University

研究点 (1)

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