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

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.

Study Overview

• Status: Completed
• Conditions: Primary Biliary Cholangitis
• Intervention / Treatment: Drug: Vitamin D

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Xinjiang
    • Urumqi, Xinjiang, China, 830001
      • People's Hospital of Xinjiang Uygur Autonomous Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; 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	Drug: Vitamin D; experimental group received UDCA combined with vitamin D3 (1200 IU per day) treatment; Other Names: Vitamin D3
No Intervention: control group; control group received UDCA(Losan Pharma GmbH, registration number H20181059, 13-15 mg/day/kg) treatment for 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Yilihamu·Abilitifu
• Investigators: Principal Investigator: Nanfang Li, Prof., People's Hospital of Xinjiang Uygur Autonomous Region

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Vitamin D; Ursodeoxycholic acid; Primary biliary cholangitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Cholangitis; Liver Cirrhosis, Biliary; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: YIHM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No