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Effects of Proteins in Patients With Cirrhosis and Prior Hepatic Encephalopathy

NCT00955500 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2009-08-10

No results posted yet for this study

Summary

The purpose of this study is to compare a normal-protein diet containing branched-chain amino acids to a low-protein diet in patients with non-terminal cirrhosis (MELD \< 25) who have developed an episode of hepatic encephalopathy within two months prior to inclusion.

Conditions

  • Hepatic Encephalopathy

Interventions

DIETARY_SUPPLEMENT

Branched-chain amino acids

30 grams of oral branched-chain amino acids (leucine: 13.5 grams, isoleucine: 9 grams, valine: 7.5 grams) daily

DIETARY_SUPPLEMENT

Maltodextrin

30 grams of oral maltodextrin daily

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Juan Córdoba, MD · Hospital Vall d'Hebron

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2008-01-31
Completion
2009-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00955500 on ClinicalTrials.gov