Recruitment

Recruitment Status
Completed
Estimated Enrollment
856

Inclusion Criterias

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

Exclusion Criterias

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

Summary

Conditions
Alcoholic Liver Disease
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

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 hematologic...

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.

Inclusion Criterias

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

Exclusion Criterias

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

Locations

New Delhi, Delhi, 110070
New Delhi, Delhi, 110070

Tracking Information

NCT #
NCT02140294
Collaborators
Not Provided
Investigators
Not Provided