- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02140294
Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease
Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease - A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delhi
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New Delhi, Delhi, India, 110070
- Institute of Liver & Biliary Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Polymeric nutritional supplement
|
|
Active Comparator: Standard Nutritional Treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess long term effect of aggressive nutritional management on survival.
Time Frame: 1 Year
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 Year
|
To assess long term effect of aggressive nutritional management on onset or progression of complication.
Time Frame: 1 Year
|
1 Year
|
|
To assess the effect of nutritional therapy on Health-related quality of life
Time Frame: 1 Year
|
1 Year
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILBS-ALD-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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