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NCT05649462 Clinical Trial

Effect of Vitamin D Supplementation on Vedolizumab Response in Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:
Retrospective Analysis of the Effect of Vitamin D Supplementation on the Clinical Efficacy of Vedelizumab in Ulcerative Colitis Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05649462
Other study ID # SAHoWMU-CR2022-07-27
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date June 1, 2022

Study information
Verified date October 2022
Source Second Affiliated Hospital of Wenzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

It is uncertain whether vitD3 supplementation is beneficial for the remission of ulcerative colitis (UC). The effects of vitD3 supplements on the efficacy of vidrecizumab in Chinese UC patients were retrospectively analyzed. Methods: Patients with moderate to severe UC were recorded. These patients were initially treated with VDZ. VitD3 supplementation was defined as 400IU/d vitD3 supplementation during the first infusion of VDZ and continued throughout the follow-up period. Disease activity was assessed using the modified Mayo score.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date June 1, 2022
Est. primary completion date November 1, 2021
Accepts healthy volunteers
Gender All
Age group 15 Years to 65 Years
Eligibility Inclusion Criteria: - moderate-to-severe UC - Treated with Vedolizumab Exclusion Criteria: - had recent supplementation of vitD3 - pregnant - had cognitive/developmental disorders that affected their ability to complete the study procedures - had medical illness or therapies potentially affecting bone, nutrition or growth status - unknown or untested baseline serum 25(OH)D level

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China SAHWenzhouMU Wenzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum 25 (OH) D level Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status. 30 weeks
Primary disease activity modified Mayo score,mild: 3 to 5, moderate: 6 to 10, severe: 11 to 12 30 weeks
Secondary drug survival Proportion of UC patients who continued to receive VDZ 54 week
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