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

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.

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Key information

Conditions

Ulcerative Colitis Avitaminosis Colitis Colitis, Ulcerative Colonic Diseases Deficiency Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency Vitamin D Supplement

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SAHWenzhouMU

Wenzhou, Zhejiang, 325000, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Serum 25 (OH) D level

Time frame: 30 weeks

Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.
disease activity

Time frame: 30 weeks

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

Secondary outcomes

drug survival

Time frame: 54 week

Proportion of UC patients who continued to receive VDZ

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2022
First posted: Dec 14, 2022
Registry last updated: Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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