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临床试验/NCT02140294
NCT02140294已完成不适用

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

Institute of Liver and Biliary Sciences, India2 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2014年5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
147
试验地点
2
主要终点
To assess long term effect of aggressive nutritional management on survival.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

To assess long term effect of aggressive nutritional management on survival.

时间窗: 1 Year

次要结局

  • To assess long term effect of aggressive nutritional management on onset or progression of complication.(1 Year)
  • To assess long term effect of aggressive nutritional management on improvement in nutritional status.(1 Year)
  • To assess the effect of nutritional therapy on Health-related quality of life(1 Year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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