Primary Biliary CholangitisNCT06309589
The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis
A study testing Vitamin D in people with Primary Biliary Cholangitis, run by Yilihamu·Abilitifu at 1 site in China.
Trial summary
The goal of this clinical trial is to compare in the effectiveness of combining ursodeoxycholic acid and vitamin D in treating patients with primary biliary cholangitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cholangitis
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must meet the diagnostic criteria for PBC ;
- The patient must have been diagnosed at the age of 18 or older;
- The patient must have completed at least 2 years of treatment and have complete and accessible clinical data;
- The patient must have strictly followed the doctor's prescription during the treatment period and not have interrupted the treatment arbitrarily.
Who cannot join
- The study excluded patients with autoimmune hepatitis or primary sclerosing cholangitis.
- Patients with other acute and chronic liver diseases were also excluded.
- Patients with serious cardiopulmonary diseases were excluded as well.
- Pregnant or lactating women were not included in the study.
- Patients who randomly interrupted or adjusted their medication during the treatment period were excluded.
- Patients who lacked follow-up were also excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001
About this study
Official title: Department of Infectious Diseases, People's Hospital of Xinjiang Uygur Autonomous Region
The goal of this clinical trial is to compare in the effectiveness of combining ursodeoxycholic acid and vitamin D in treating patients with primary biliary cholangitis.
Read the detailed description
A prospective analysis will be conducted on 60 patients with primary PBC who were admitted to our Infectious Diseases Department and outpatient clinic. All patients will take UDCA capsules orally and divide into two groups: the experimental group, which received UDCA combined with Vitamin D(1200 IU per day) treatment, and the control group. The control group will receive UDCA treatment alone for one year, selected through a random number table method. After one year, the control group will be further divided into two groups using the same method. One group will continue to receive UDCA alone, while the other will receive a combination of UDCA and vitamin D for an additional year. Clinical data, clinical manifestations, blood tests, and imaging tests will be collected during the initial and subsequent treatments. The efficacy will be evaluated using the Paris I and Barcelona standards.
- Conditions
- Primary Biliary Cholangitis
- Being tested
- Vitamin D
- Keywords
- Primary biliary cholangitis, Ursodeoxycholic acid, Vitamin D
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Vitamin D3
experimental group received UDCA combined with vitamin D3 (1200 IU per day) treatment
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | experimental group received UDCA(Losan Pharma GmbH, registration number H20181059, 13-15 mg/day/kg) combined with Vitamin D3 (1200 IU per day) treatment for 1year Receives: Drug: Vitamin D |
| control group | No intervention | control group received UDCA(Losan Pharma GmbH, registration number H20181059, 13-15 mg/day/kg) treatment for 1 year |
What is being measured
The primary outcome is the main question the study is designed to answer.
UDCA response: Paris I criteria
The ALP levels should be no more than three times the upper limit of normal (3xULN), while the AST levels should be no more than two times the ULN, and bilirubin levels should be normal after one year of standard treatment.
Measured: 1 year
UDCA response: Barcelona criteria
After one year of standard treatment, the ALP levels should decrease by more than 40% or reach normal levels.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 May 2021
- Primary completion30 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CholangitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yilihamu·Abilitifu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yilihamu·Abilitifu, People's Hospital of Xinjiang Uygur Autonomous Region
- Investigators
- Nanfang Li, Prof., Principal investigator, People's Hospital of Xinjiang Uygur Autonomous Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309589
- Sponsor's protocol ID
- YIHM
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Infectious Diseases, People's Hospital of Xinjiang Uygur Autonomous Region
- ClinicalTrials.gov ID
- NCT06309589
- Acronym / sponsor ID
- YIHM
- Conditions
- Primary Biliary Cholangitis
- Keywords
- Primary biliary cholangitis, Ursodeoxycholic acid, Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yilihamu·AbilitifuUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Mar 2024 (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.
The goal of this clinical trial is to compare in the effectiveness of combining ursodeoxycholic acid and vitamin D in treating patients with primary biliary cholangitis.
Detailed description
A prospective analysis will be conducted on 60 patients with primary PBC who were admitted to our Infectious Diseases Department and outpatient clinic. All patients will take UDCA capsules orally and divide into two groups: the experimental group, which received UDCA combined with Vitamin D(1200 IU per day) treatment, and the control group. The control group will receive UDCA treatment alone for one year, selected through a random number table method. After one year, the control group will be further divided into two groups using the same method. One group will continue to receive UDCA alone, while the other will receive a combination of UDCA and vitamin D for an additional year. Clinical data, clinical manifestations, blood tests, and imaging tests will be collected during the initial and subsequent treatments. The efficacy will be evaluated using the Paris I and Barcelona standards.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Vitamin Dexperimental group received UDCA(Losan Pharma GmbH, registration number H20181059, 13-15 mg/day/kg) combined with Vitamin D3 (1200 IU per day) treatment for 1year |
| control group | No intervention | –control group received UDCA(Losan Pharma GmbH, registration number H20181059, 13-15 mg/day/kg) treatment for 1 year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must meet the diagnostic criteria for PBC ;
- The patient must have been diagnosed at the age of 18 or older;
- The patient must have completed at least 2 years of treatment and have complete and accessible clinical data;
- The patient must have strictly followed the doctor's prescription during the treatment period and not have interrupted the treatment arbitrarily.
Key exclusion criteria (6 listed)
- The study excluded patients with autoimmune hepatitis or primary sclerosing cholangitis.
- Patients with other acute and chronic liver diseases were also excluded.
- Patients with serious cardiopulmonary diseases were excluded as well.
- Pregnant or lactating women were not included in the study.
- Patients who randomly interrupted or adjusted their medication during the treatment period were excluded.
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 |
|---|---|---|
| Vitamin DAlso: Vitamin D3experimental group received UDCA combined with vitamin D3 (1200 IU per day) treatment | Drug | experimental group |
Primary outcome
UDCA response: Paris I criteria
Time frame: 1 year
The ALP levels should be no more than three times the upper limit of normal (3xULN), while the AST levels should be no more than two times the ULN, and bilirubin levels should be normal after one year of standard treatment.
UDCA response: Barcelona criteria
Time frame: 1 year
After one year of standard treatment, the ALP levels should decrease by more than 40% or reach normal levels.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Primary Biliary Cholangitis
Active, not recruitingPhase 3
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cirrhosis
RecruitingPhase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Primary Biliary Cholangitis
RecruitingPhase 3
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
Primary Biliary Cholangitis (PBC)
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis
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. This study is not recruiting at the moment.
Nanfang Li, Prof. principal investigator
People's Hospital of Xinjiang Uygur Autonomous Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Primary Biliary Cholangitis, run by Yilihamu·Abilitifu at 1 site in China.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 13 Mar 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UDCA response: Paris I criteria (time frame: 1 year). The study lists 2 primary outcomes in all. 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 13 Mar 2024.