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

NCT ID: NCT02140294

Last Updated: 2016-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Alcoholic Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Polymeric nutritional supplement

Group Type: EXPERIMENTAL

Polymeric nutritional supplements

Intervention Type: DIETARY_SUPPLEMENT

Standard Nutritional Treatment

Group Type: ACTIVE_COMPARATOR

Standard Nutrional Treatment

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Polymeric nutritional supplements

Intervention Type: DIETARY_SUPPLEMENT

Standard Nutrional Treatment

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

References

Kalal C, Benjamin J, Shasthry V, Kumar G, Sharma MK, Joshi YK, Sarin SK. Effect of long-term aggressive nutrition therapy on survival in patients with alcohol-related cirrhosis: A randomized controlled trial. Indian J Gastroenterol. 2022 Feb;41(1):52-62. doi: 10.1007/s12664-021-01187-3. Epub 2022 Mar 2.

Reference Type: DERIVED

PMID: 35235198 (View on PubMed)

Other Identifiers

ILBS-ALD-01

Identifier Type: -

Identifier Source: org_study_id