People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001, China
NCT Number: NCT06309589
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Ürümqi, Xinjiang, 830001, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
experimental group received UDCA combined with vitamin D3 (1200 IU per day) treatment
Other names: Vitamin D3
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.
Time frame: 1 year
After one year of standard treatment, the ALP levels should decrease by more than 40% or reach normal levels.
Yilihamu·Abilitifu
Other
Department of Infectious Diseases, People's Hospital of Xinjiang Uygur Autonomous Region
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