Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease
Primary Purpose
Alcoholic Liver Disease
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Polymeric nutritional supplements
Standard Nutrional Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholic Liver Disease
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
Sites / Locations
- Institute of Liver & Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Polymeric nutritional supplement
Standard Nutritional Treatment
Arm Description
Outcomes
Primary Outcome Measures
To assess long term effect of aggressive nutritional management on survival.
Secondary Outcome Measures
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.
To assess long term effect of aggressive nutritional management on onset or progression of complication.
To assess the effect of nutritional therapy on Health-related quality of life
Full Information
NCT ID
NCT02140294
First Posted
April 9, 2014
Last Updated
February 9, 2016
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT02140294
Brief Title
Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease
Official Title
Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease - A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polymeric nutritional supplement
Arm Type
Experimental
Arm Title
Standard Nutritional Treatment
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Polymeric nutritional supplements
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard Nutrional Treatment
Primary Outcome Measure Information:
Title
To assess long term effect of aggressive nutritional management on survival.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
To assess long term effect of aggressive nutritional management on improvement in nutritional status.
Description
Nutritional Status will be measured by Royal Free Hospital-Global Assessment (RFH-GA) method.
Time Frame
1 Year
Title
To assess long term effect of aggressive nutritional management on onset or progression of complication.
Time Frame
1 Year
Title
To assess the effect of nutritional therapy on Health-related quality of life
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
35235198
Citation
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.
Results Reference
derived
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Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease
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