Branched Chain Aminoacid Supplementation in Patients With Liver Cirrhosis

Phase 4

Completed

• Conditions: Liver Cirrhosis

• Registration Number: NCT02023229
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-01
• Study Completion: 2013-05
• Status Verified: 2013-12
• Study First Submitted: 2013-12-23
• Study First Submitted QC: 2013-12-23
• Last Update Submitted: 2013-12-23
• Study First Posted: 2013-12-30
• Last Update Posted: 2013-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Nutritional status	At time of recruitment	Assessed by bioelectrical impedance vector analysis and mid-arm muscle circumference

Secondary Outcome Measures

Name	Time	Method
Hepatic Encephalopathy	At time of recruitment

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"; 🇲🇽 Mexico city, Mexico