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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06309589
Other study ID # YIHM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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