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

NCT06309589 | Completed DMC

• 1 other identifier: YIHM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Biliary Cholangitis

Keywords

Primary biliary cholangitis; Ursodeoxycholic acid; Vitamin D

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

NO INTERVENTION

control group received UDCA(Losan Pharma GmbH, registration number H20181059, 13-15 mg/day/kg) treatment for 1 year

Interventions

Vitamin D DRUG

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

Also known as: Vitamin D3

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yilihamu·Abilitifu: lead

Study Sites (1)

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830001, China

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Nanfang Li, Prof.

  People's Hospital of Xinjiang Uygur Autonomous Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: People's Hospital of Xinjiang Uygur Autonomous Region

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 13, 2024
• Study Start: May 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)