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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05649462
Enrollment
80
Registered
2022-12-14
Start date
2020-01-01
Completion date
2022-06-01
Last updated
2022-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis, Vitamin D Deficiency, Vitamin D Supplement

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.

Interventions

None listed

Sponsors

Second Affiliated Hospital of Wenzhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 65 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Serum 25 (OH) D level30 weeksBecause serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.
disease activity30 weeksmodified Mayo score,mild: 3 to 5, moderate: 6 to 10, severe: 11 to 12

Secondary

MeasureTime frameDescription
drug survival54 weekProportion of UC patients who continued to receive VDZ

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026