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

Not Applicable

Completed

• Conditions: Primary Biliary Cholangitis
• Interventions: Drug: Vitamin D

• Registration Number: NCT06309589
• Lead Sponsor: Yilihamu·Abilitifu

Brief 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.

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 Timeline

• Study Start: 2021-05-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-13
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	Vitamin D	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

Primary Outcome Measures

Name	Time	Method
UDCA response: Paris I criteria	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	1 year	After one year of standard treatment, the ALP levels should decrease by more than 40% or reach normal levels.

Trial Locations

Locations (1)

People's Hospital of Xinjiang Uygur Autonomous Region; 🇨🇳 Urumqi, Xinjiang, China