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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Alcoholic Liver Disease

Treatments: Dietary Supplement: Standard Nutrional Treatment; Dietary Supplement: Polymeric nutritional supplements

Study type: Interventional

Funder types: Other

Identifiers

NCT02140294

ILBS-ALD-01

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 147 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 2 patient groups

Polymeric nutritional supplement

Experimental group

Treatment:

Dietary Supplement: Polymeric nutritional supplements

Standard Nutritional Treatment

Active Comparator group

Treatment:

Dietary Supplement: Standard Nutrional Treatment