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

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Completed

CT.gov ID

NCT02140294

Collaborator

(none)

147

Enrollment

Location

Arms

Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholic Liver Disease	Dietary Supplement: Polymeric nutritional supplements Dietary Supplement: Standard Nutrional Treatment	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

147 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Polymeric nutritional supplement	Dietary Supplement: Polymeric nutritional supplements
Active Comparator: Standard Nutritional Treatment	Dietary Supplement: Standard Nutrional Treatment

Arm

Intervention/Treatment

Experimental: Polymeric nutritional supplement

Dietary Supplement: Polymeric nutritional supplements

Active Comparator: Standard Nutritional Treatment

Dietary Supplement: Standard Nutrional Treatment

Outcome Measures

Primary Outcome Measures

To assess long term effect of aggressive nutritional management on survival. [1 Year]

Secondary Outcome Measures

To assess long term effect of aggressive nutritional management on improvement in nutritional status. [1 Year]
Nutritional Status will be measured by Royal Free Hospital-Global Assessment (RFH-GA) method.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver & Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institute of Liver and Biliary Sciences, India

ClinicalTrials.gov Identifier:

NCT02140294

Other Study ID Numbers:

ILBS-ALD-01

First Posted:

May 16, 2014

Last Update Posted:

Feb 11, 2016

Last Verified:

Feb 1, 2016

Additional relevant MeSH terms:

Liver Diseases

Liver Diseases, Alcoholic

Study Results

No Results Posted as of Feb 11, 2016