NCT00955500

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2009

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 10, 2009

Completed
Last Updated

August 10, 2009

Status Verified

August 1, 2009

Enrollment Period

5 years

First QC Date

July 21, 2009

Last Update Submit

August 7, 2009

Conditions

Hepatic Encephalopathy

Keywords

Hepatic encephalopathyCirrhosisProteins of the dietBranched-chain amino acids

Outcome Measures

Primary Outcomes (1)

  • Hepatic encephalopathy-free survival

    56 weeks

Secondary Outcomes (5)

  • Overall duration in days of episodic hepatic encephalopathy

    56 weeks

  • Minimal hepatic encephalopathy assessed by neuropsychological tests

    56 weeks

  • Health-related quality of life

    56 weeks

  • Nutritional status

    56 weeks

  • Liver function

    56 weeks

Study Arms (2)

Normal-protein diet

ACTIVE COMPARATOR

Daily diet containing 35 kcal/kg/day, 0.7 grams of proteins/kg/day + 30 grams of oral branched-chain amino acids (leucine: 13.5 grams, isoleucine: 9 grams, valine: 7.5 grams).

Dietary Supplement: Branched-chain amino acids

Low-protein diet

ACTIVE COMPARATOR

Daily diet containing 35 kcal/kg/day, 0.7 grams of proteins/kg/day + 30 grams of oral maltodextrine

Dietary Supplement: Maltodextrin

Interventions

Branched-chain amino acidsDIETARY_SUPPLEMENT

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

Normal-protein diet
MaltodextrinDIETARY_SUPPLEMENT

30 grams of oral maltodextrin daily

Low-protein diet

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cirrhosis of the liver.

You may not qualify if:

  • End-stage cirrhosis (MELD score \> 25).
  • Marked cognitive disorder (mini-mental test \< 27).
  • Non-treatable hepatocarcinoma in accordance with Milan criteria.
  • Comorbid conditions with a life expectancy less than 6 months.
  • Neurological conditions that difficult assessment of treatment of hepatic encephalopathy (dementia, encephalitis, severe depression).
  • Diseases requiring administration of a specific diet (malabsorption, chronic diarrhea, chronic pancreatic insufficiency, severe obesity).
  • No acceptation of written consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital de Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Hepatic EncephalopathyFibrosis

Interventions

Amino Acids, Branched-Chainmaltodextrin

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Juan Córdoba, MD

    Hospital Vall d'Hebron

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2009

First Posted

August 10, 2009

Study Start

January 1, 2003

Primary Completion

January 1, 2008

Study Completion

January 1, 2009

Last Updated

August 10, 2009

Record last verified: 2009-08

Locations

ES(3)