NCT06309589

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Yilihamu·Abilitifu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	Vitamin D	experimental group received UDCA combined with vitamin D3 (1200 IU per day) treatment

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2024-03-13
• Last updated: 2024-03-13

Locations

1 site across 1 country: China