Cirrhosis, LiverNCT05729438
Nutritional Assesment in Patients With Cirrhosis
An observational study of Cirrhosis, Liver, run by SUUMC Central Military Hospital Dr Carol Davila at 1 site in Romania.
Trial summary
This study aims to evaluated nutritional status in patiets with cirrhosis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- BCAA
- How many people
- 50 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: patients males and females with hepatic cirrhosis
Who may be able to join
- signed informed consent
- age >18, <75 years old
- hepatic cirrhosis diagnosis
Who cannot join
- refuse to participate/to give consent
- presence of musculo-skeletal disease previous diagnosed, neuropathic diseases, malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Suumc
Bucharest, București - Sector1, 010825
SANDICA BUCURICA, bucuricasandy@yahoo.com
About this study
This study aims to evaluated nutritional status in patiets with cirrhosis
- Conditions
- Cirrhosis, Liver
- Being tested
- BCAA
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCAADietary supplement
Also called branched chain amino acids
status of nutrition evaluation after 3 months of BCAA
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle mass change
muscle mass changes in DEXA or body composition measurement
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SUUMC Central Military Hospital Dr Carol Davila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bucurica Sandica, SUUMC Central Military Hospital Dr Carol Davila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729438
- Sponsor's protocol ID
- 559
- Status last verified
- Dec 2024
- First submitted
- 31 Jan 2023
- Last updated
- 19 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Assesment in Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT05729438
- Acronym / sponsor ID
- 559
- Conditions
- Cirrhosis, Liver
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SUUMC Central Military Hospital Dr Carol DavilaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluated nutritional status in patiets with cirrhosis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients males and females with hepatic cirrhosis
Key inclusion criteria (3 listed)
- signed informed consent
- age >18, <75 years old
- hepatic cirrhosis diagnosis
Key exclusion criteria (2 listed)
- refuse to participate/to give consent
- presence of musculo-skeletal disease previous diagnosed, neuropathic diseases, malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCAAAlso: branched chain amino acidsstatus of nutrition evaluation after 3 months of BCAA | Dietary supplement | – |
Primary outcome
muscle mass change
Time frame: 3 months
muscle mass changes in DEXA or body composition measurement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, Liver, run by SUUMC Central Military Hospital Dr Carol Davila at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SANDICA BUCURICA (0213193051, bucuricasandy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle mass change (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.