Clinical Trial: Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease - A Randomized Control Trial
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: Institute of Liver and Biliary Sciences, India
Current Primary Outcome: To assess long term effect of aggressive nutritional management on survival. [ Time Frame: 1 Year ]
Original Primary Outcome: To assess the effect of nutritional therapy on overall survival [ Time Frame: 1 Year ]
Current Secondary Outcome:
- To assess long term effect of aggressive nutritional management on improvement in nutritional status. [ Time Frame: 1 Year ]Nutritional Status will be measured by Royal Free Hospital-Global Assessment (RFH-GA) method.
- To assess long term effect of aggressive nutritional management on onset or progression of complication. [ Time Frame: 1 Year ]
- To assess the effect of nutritional therapy on Health-related quality of life [ Time Frame: 1 Year ]
Original Secondary Outcome:
- To assess the effect of nutritional therapy on nutritional status [ Time Frame: 1 Year ]Nutritional Status will be measured by Royal Free Hospital-Global Assessment (RFH-GA) method.
- To assess the effect of nutritional therapy on hepatic morbidity (appearance or failure of resolution of ascites, appearance of gastrointestinal bleeding, appearance of hepatic encephalopathy, development of infection and acute kidney injury) [ Time Frame: 1 Year ]
- To assess the effect of nutritional therapy on Health-related quality of life [ Time Frame: 1 Year ]
Information By: Institute of Liver and Biliary Sciences, India
Dates:
Date Received: April 9, 2014
Date Started: May 2014
Date Completion:
Last Updated: February 9, 2016
Last Verified: February 2016
