Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease
1 other identifier
interventional
147
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 11, 2016
February 1, 2016
1.6 years
April 9, 2014
February 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
To assess long term effect of aggressive nutritional management on survival.
1 Year
Secondary Outcomes (3)
To assess long term effect of aggressive nutritional management on improvement in nutritional status.
1 Year
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
Study Arms (2)
Polymeric nutritional supplement
EXPERIMENTALStandard Nutritional Treatment
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- All consecutive malnourished patients with ALD aged between 18 to 65 years of either gender would be enrolled.
- Abstinence of three months.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Related Publications (1)
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.
PMID: 35235198DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2014
First Posted
May 16, 2014
Study Start
May 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 11, 2016
Record last verified: 2016-02