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Branched Chain Aminoacid Supplementation in Patients With Liver Cirrhosis

Primary Purpose

Liver Cirrhosis

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Branched-chain aminoacids
High-fiber high protein diet
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Branched chain aminoacids, Nutritional status, Hepatic encephalopathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ambulatory patients Patients with confirmed diagnose of liver cirrhosis Patients classified as Child-Pugh A or Child Pugh B

Exclusion Criteria:

Acute or chronic renal failure Pregnancy Overt hepatic encephalopathy

Sites / Locations

  • Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diet plus branched chain aminoacids

Diet

Arm Description

High-fiber high-protein diet Oral supplement : branched chain aminoacids

High-fiber high-protein diet

Outcomes

Primary Outcome Measures

Nutritional status
Assessed by bioelectrical impedance vector analysis and mid-arm muscle circumference

Secondary Outcome Measures

Hepatic Encephalopathy

Full Information

First Posted
December 23, 2013
Last Updated
December 23, 2013
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT02023229
Brief Title
Branched Chain Aminoacid Supplementation in Patients With Liver Cirrhosis
Official Title
High-fiber High-fiber Diet and Branched Chain Aminoacids. Impact on Nutritional Status and Complications in Patients With Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Malnutrition is a frequent complication in patients with liver cirrhosis. Most patients have decreased dietary intake due to ascites, hepatic encephalopathy and pro-inflammatory cytokines. We hypothesized that branched chain aminoacids can improve nutritional status and delay episodes of hepatic encephalopathy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Branched chain aminoacids, Nutritional status, Hepatic encephalopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet plus branched chain aminoacids
Arm Type
Experimental
Arm Description
High-fiber high-protein diet Oral supplement : branched chain aminoacids
Arm Title
Diet
Arm Type
Active Comparator
Arm Description
High-fiber high-protein diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Branched-chain aminoacids
Intervention Type
Other
Intervention Name(s)
High-fiber high protein diet
Primary Outcome Measure Information:
Title
Nutritional status
Description
Assessed by bioelectrical impedance vector analysis and mid-arm muscle circumference
Time Frame
At time of recruitment
Secondary Outcome Measure Information:
Title
Hepatic Encephalopathy
Time Frame
At time of recruitment
Other Pre-specified Outcome Measures:
Title
Nutritional status
Description
Assessed by bioelectrical impedance vector analysis and mid-arm muscle circumference
Time Frame
3 months follow-up
Title
Nutritional status
Description
Assessed by bioelectrical impedance vector analysis and mid-arm muscle circumference
Time Frame
6 months follow-up
Title
Hepatic encephalopathy
Time Frame
6 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ambulatory patients Patients with confirmed diagnose of liver cirrhosis Patients classified as Child-Pugh A or Child Pugh B Exclusion Criteria: Acute or chronic renal failure Pregnancy Overt hepatic encephalopathy
Facility Information:
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
City
Mexico city
ZIP/Postal Code
14000
Country
Mexico

12. IPD Sharing Statement

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Branched Chain Aminoacid Supplementation in Patients With Liver Cirrhosis

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