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

Alcoholic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140294
• Other study ID #: ILBS-ALD-01
• Status: Completed
• Phase: N/A
• First received: April 9, 2014
• Last updated: February 9, 2016
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholic Liver Disease
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

Dietary Supplement:
• Polymeric nutritional supplements

• Standard Nutrional Treatment

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess long term effect of aggressive nutritional management on survival.		1 Year	No
Secondary	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	No
Secondary	To assess long term effect of aggressive nutritional management on onset or progression of complication.		1 Year	No
Secondary	To assess the effect of nutritional therapy on Health-related quality of life		1 Year	No