The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis

Primary Biliary Cholangitis Clinical Trial

Official title:

Department of Infectious Diseases, People's Hospital of Xinjiang Uygur Autonomous Region

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06309589
• Other study ID #: YIHM
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: People's Hospital of Xinjiang Uygur Autonomous Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The patient must meet the diagnostic criteria for PBC ;

2. The patient must have been diagnosed at the age of 18 or older;

3. The patient must have completed at least 2 years of treatment and have complete and accessible clinical data;

4. The patient must have strictly followed the doctor's prescription during the treatment period and not have interrupted the treatment arbitrarily.

Exclusion Criteria:

1. The study excluded patients with autoimmune hepatitis or primary sclerosing cholangitis.

2. Patients with other acute and chronic liver diseases were also excluded.

3. Patients with serious cardiopulmonary diseases were excluded as well.

4. Pregnant or lactating women were not included in the study.

5. Patients who randomly interrupted or adjusted their medication during the treatment period were excluded.

6. Patients who lacked follow-up were also excluded.

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis

Intervention

Drug:
• Vitamin D
experimental group received UDCA combined with vitamin D3 (1200 IU per day) treatment

Locations

Country	Name	City	State
China	People's Hospital of Xinjiang Uygur Autonomous Region	Urumqi	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Yilihamu·Abilitifu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	UDCA response: Barcelona criteria	After one year of standard treatment, the ALP levels should decrease by more than 40% or reach normal levels.	1 year