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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polymeric nutritional supplement | Experimental |
| |
| Standard Nutritional Treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polymeric nutritional supplements | Dietary Supplement |
| ||
| Standard Nutrional Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To assess long term effect of aggressive nutritional management on survival. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| To assess long term effect of aggressive nutritional management on improvement in nutritional status. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35235198 | Derived | Kalal C, Benjamin J, Shasthry V, Kumar G, Sharma MK, Joshi YK, Sarin SK. Effect of long-term aggressive nutrition therapy on survival in patients with alcohol-related cirrhosis: A randomized controlled trial. Indian J Gastroenterol. 2022 Feb;41(1):52-62. doi: 10.1007/s12664-021-01187-3. Epub 2022 Mar 2. |
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| ID | Term |
|---|---|
| D008108 | Liver Diseases, Alcoholic |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
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| Dietary Supplement |
|
| 1 Year |
| To assess the effect of nutritional therapy on Health-related quality of life | 1 Year |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |