Skip to main content
OpenTrials
Completed

NCT Number: NCT02140294

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polymeric nutritional supplements

Dietary Supplement

Standard Nutrional Treatment

Dietary Supplement

Primary outcomes

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

    Time frame: 1 Year

Secondary outcomes

  1. To assess long term effect of aggressive nutritional management on improvement in nutritional status.

    Time frame: 1 Year

    Nutritional Status will be measured by Royal Free Hospital-Global Assessment (RFH-GA) method.

  2. To assess long term effect of aggressive nutritional management on onset or progression of complication.

    Time frame: 1 Year

  3. To assess the effect of nutritional therapy on Health-related quality of life

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 16, 2014
Registry last updated
Feb 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.