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

Completed

• Conditions: Ulcerative Colitis; Vitamin D Supplement; Vitamin D Deficiency

• Registration Number: NCT05649462
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-11-01
• Study Completion: 2022-06-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-12-13
• Last Update Submitted: 2022-12-13
• Study First Posted: 2022-12-14
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum 25 (OH) D level	30 weeks	Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.
disease activity	30 weeks	modified Mayo score，mild: 3 to 5, moderate: 6 to 10, severe: 11 to 12

Secondary Outcome Measures

Name	Time	Method
drug survival	54 week	Proportion of UC patients who continued to receive VDZ

Trial Locations

Locations (1)

SAHWenzhouMU; 🇨🇳 Wenzhou, Zhejiang, China