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

NCT05649462 | Completed

• 1 other identifier: SAHoWMU-CR2022-07-27
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Vitamin D Deficiency; Vitamin D Supplement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• drug survival

  54 week

Study Arms (2)

supplementary group

take vitamin D supplementation (400 IU/day) during VDZ treatment

non-supplementary group

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese

You may qualify if:

• moderate-to-severe UC
• Treated with Vedolizumab

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

SAHWenzhouMU

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Xia shenglong, Master

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: December 14, 2022
• Study Start: January 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: June 1, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-10

Locations

CN (1)