Skip to main content
OpenTrials
Completed

NCT Number: NCT06309589

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Vitamin D

Drug

experimental group received UDCA combined with vitamin D3 (1200 IU per day) treatment

Other names: Vitamin D3

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Yilihamu·Abilitifu

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2024
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.