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

Second Affiliated Hospital of Wenzhou Medical University80 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ulcerative Colitis Vitamin D Deficiency Vitamin D Supplement

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

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.

Time frame: 30 weeks

disease activity

modified Mayo score，mild: 3 to 5, moderate: 6 to 10, severe: 11 to 12

Time frame: 30 weeks

Secondary Outcomes

drug survival

Proportion of UC patients who continued to receive VDZ

Time frame: 54 week