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Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease

Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease - A Randomized Control Trial

Patient found to be malnourished after the nutritional evaluation would be randomized in the two groups of the study. The control group would receive standard nutritional counseling from a trained dietician where as those in the intervention group would be given 120 gm of a polymeric nutritional supplement providing around 500 Kcal per day over and above the standard nutritional counseling from a trained dietician. Both the groups would receive standard medical treatment. The polymeric nutrient supplement would be taken by the patients in this arm for a period of 6 months.

研究概览

详细说明

Patients with ALD (Alcoholic Liver Disease) would undergo a detailed clinical evaluation. Information would be collected regarding the onset and duration of symptoms, etiology, and severity of disease, other baseline clinical features, demographic characteristics, routine biochemical and hematological investigations, upper GI endoscopic findings and radiological investigations, patients would also be screened for the assessment of nutritional status. Patient found to be malnourished after the nutritional evaluation would be randomized in the two groups of the study. The control group would receive standard nutritional counseling from a trained dietician where as those in the intervention group would be given 120 gm of a polymeric nutritional supplement providing around 500 Kcal per day over and above the standard nutritional counseling from a trained dietician. Both the groups would receive standard medical treatment. The polymeric nutrient supplement would be taken by the patients in this arm for a period of 6 months. A record would be kept for the medications taken by the patients.

All the patients would be followed up at 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after inclusion. Clinical, nutritional and biological data were collected at each visit. All these patients would receive standard treatment of cirrhosis consisting of withdrawal from alcohol along with symptomatic treatment including B vitamins, diuretics, salt restriction, lactulose, beta blockers, and antibiotics after bacteriological samples if needed. All patients would receive endoscopic surveillance for portal hypertension. An adequate prophylaxis by ligation or beta blockers would be performed as needed. The patients with a past history of spontaneous bacterial peritonitis will receive antibiotic prophylaxis.

研究类型

介入性

注册 (实际的)

147

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Delhi
      • New Delhi、Delhi、印度、110070
        • Institute of Liver & Biliary Sciences

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • All consecutive malnourished patients with ALD aged between 18 to 65 years of either gender would be enrolled.
  • Abstinence of three months.

Exclusion Criteria:

  • Severe alcoholic hepatitis
  • Uncontrolled complication of the cirrhosis (variceal bleeding, infection, etc.),
  • Hepatocellular carcinoma
  • Ongoing corticosteroid treatment
  • Co morbidities e.g. chronic renal insufficiency & Acquired immunodeficiency syndrome.
  • Refusal to participate in the trial

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Polymeric nutritional supplement
有源比较器:Standard Nutritional Treatment

研究衡量的是什么?

主要结果指标

结果测量
大体时间
To assess long term effect of aggressive nutritional management on survival.
大体时间:1 Year
1 Year

次要结果测量

结果测量
措施说明
大体时间
To assess long term effect of aggressive nutritional management on improvement in nutritional status.
大体时间:1 Year
Nutritional Status will be measured by Royal Free Hospital-Global Assessment (RFH-GA) method.
1 Year
To assess long term effect of aggressive nutritional management on onset or progression of complication.
大体时间:1 Year
1 Year
To assess the effect of nutritional therapy on Health-related quality of life
大体时间:1 Year
1 Year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年5月1日

初级完成 (实际的)

2015年12月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2014年4月9日

首先提交符合 QC 标准的

2014年5月15日

首次发布 (估计)

2014年5月16日

研究记录更新

最后更新发布 (估计)

2016年2月11日

上次提交的符合 QC 标准的更新

2016年2月9日

最后验证

2016年2月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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