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

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

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 Overview

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

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • SAHWenzhouMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 63 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chinese

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
supplementary group; take vitamin D supplementation (400 IU/day) during VDZ treatment
non-supplementary group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
disease activity	modified Mayo score，mild: 3 to 5, moderate: 6 to 10, severe: 11 to 12	30 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
drug survival	Proportion of UC patients who continued to receive VDZ	54 week

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: Xia shenglong, Master, Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Estimate): December 14, 2022

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Nutrition Disorders; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Inflammatory Bowel Diseases; Ulcer; Vitamin D Deficiency; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: SAHoWMU-CR2022-07-27

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No