MedDataX Logo

Branched Chain Aminoacid Supplementation in Patients With Liver Cirrhosis

NCT ID: NCT02023229

Last Updated: 2013-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Cirrhosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Branched chain aminoacids Nutritional status Hepatic encephalopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diet plus branched chain aminoacids

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

Group Type EXPERIMENTAL

Branched-chain aminoacids

Intervention Type DIETARY_SUPPLEMENT

High-fiber high protein diet

Intervention Type OTHER

Diet

High-fiber high-protein diet

Group Type ACTIVE_COMPARATOR

High-fiber high protein diet

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Branched-chain aminoacids

Intervention Type DIETARY_SUPPLEMENT

High-fiber high protein diet

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ALDO TORRE DELGADILLO

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Mexico City, , Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Enterex01

Identifier Type: -

Identifier Source: org_study_id