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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Alcoholic Liver Disease

Intervention / Treatment
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* Dietary Supplement: Polymeric nutritional supplements
* Dietary Supplement: Standard Nutrional Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polymeric nutritional supplement<br> | Dietary Supplement: Polymeric nutritional supplements<br> <br> |
| Active Comparator: Standard Nutritional Treatment<br> | Dietary Supplement: Standard Nutrional Treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess long term effect of aggressive nutritional management on survival. |  | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 1 Year | 
| To assess the effect of nutritional therapy on Health-related quality of life |  | 1 Year |