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NCT05867784 Clinical Trial

Effect of Vitamin D Supplementation on the Efficacy of Ustekinumab in the Treatment of Crohn's Disease

Crohn's Disease Clinical Trial

Official title:
Effect of Vitamin D Supplementation on the Efficacy of Ustekinumab in the Treatment of Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05867784
Other study ID # SAHoWMU-CR2023-01-203
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 30, 2021
Est. completion date March 15, 2023

Study information
Verified date May 2023
Source Second Affiliated Hospital of Wenzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

It is uncertain whether vitD3 supplementation is beneficial for the remission of Crohn's disease (CD). The effects of vitD3 supplements on the efficacy of ustekinumab in Chinese CD patients were retrospectively analyzed. Methods: Patients with moderate to severe CD were recorded. These patients were initially treated with UST. VitD3 supplementation was defined as 400IU/d vitD3 supplementation during the first infusion of UST and continued throughout the follow-up period. Disease activity was assessed using Harvey Bradshaw Index.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date March 15, 2023
Est. primary completion date February 15, 2022
Accepts healthy volunteers
Gender All
Age group 15 Years to 65 Years
Eligibility Inclusion Criteria: - moderate-to-severe CD - Treated with Ustekinumab 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
China SAHWenzhouMU Wenzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum 25 (OH) D level Vitamin D deficiency is defined as serum 25 (OH) D level<20 µ g/L 24 weeks
Primary disease activity Harvey Bradshaw Index,mild: 0 to 8, moderate: 9 to 16, severe: 17 to 25 24weeks
Secondary Serum 25 (OH) D level Vitamin D deficiency is defined as serum 25 (OH) D level<20 µ g/L 8 weeks
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