NCT05729438

Brief Summary

This study aims to evaluated nutritional status in patiets with cirrhosis

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

January 31, 2023

Last Update Submit

December 15, 2024

Conditions

Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

  • muscle mass change

    muscle mass changes in DEXA or body composition measurement

    3 months

Interventions

BCAADIETARY_SUPPLEMENT

status of nutrition evaluation after 3 months of BCAA

Also known as: branched chain amino acids

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients males and females with hepatic cirrhosis

You may qualify if:

  • signed informed consent
  • age \>18, \<75 years old
  • hepatic cirrhosis diagnosis

You may not qualify if:

  • refuse to participate/to give consent
  • presence of musculo-skeletal disease previous diagnosed, neuropathic diseases, malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suumc

Bucharest, București - Sector1, 010825, Romania

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Central Study Contacts

SANDICA BUCURICA

CONTACT

0213193051bucuricasandy@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Head of Functional Exploring Laboratory

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 15, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

December 19, 2024

Record last verified: 2024-12

Locations

RO(1)