NCT02023229

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
Last Updated

December 30, 2013

Status Verified

December 1, 2013

Enrollment Period

2 years

First QC Date

December 23, 2013

Last Update Submit

December 23, 2013

Conditions

Liver Cirrhosis

Keywords

Branched chain aminoacidsNutritional statusHepatic encephalopathy

Outcome Measures

Primary Outcomes (1)

  • Nutritional status

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

    At time of recruitment

Secondary Outcomes (1)

  • Hepatic Encephalopathy

    At time of recruitment

Other Outcomes (3)

  • Nutritional status

    3 months follow-up

  • Nutritional status

    6 months follow-up

  • Hepatic encephalopathy

    6 months follow-up

Study Arms (2)

Diet plus branched chain aminoacids

EXPERIMENTAL

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

Dietary Supplement: Branched-chain aminoacidsOther: High-fiber high protein diet

Diet

ACTIVE COMPARATOR

High-fiber high-protein diet

Other: High-fiber high protein diet

Interventions

Branched-chain aminoacidsDIETARY_SUPPLEMENT
Diet plus branched chain aminoacids
High-fiber high protein dietOTHER
DietDiet plus branched chain aminoacids

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Acute or chronic renal failure Pregnancy Overt hepatic encephalopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Mexico City, 14000, Mexico

Location

MeSH Terms

Conditions

Liver CirrhosisHepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsLiver FailureHepatic InsufficiencyBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 23, 2013

First Posted

December 30, 2013

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

May 1, 2013

Last Updated

December 30, 2013

Record last verified: 2013-12

Locations

ME(1)