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

Completed

• Conditions: Ustekinumab; Vitamin D Supplementation; Crohn's Disease; Clinical Efficacy

• Registration Number: NCT05867784
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-30
• Primary Completion: 2022-02-15
• Study Completion: 2023-03-15
• Status Verified: 2023-05
• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-18
• Last Update Submitted: 2023-05-18
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum 25 (OH) D level	24 weeks	Vitamin D deficiency is defined as serum 25 (OH) D level\<20 μ g/L
disease activity	24weeks	Harvey Bradshaw Index，mild: 0 to 8, moderate: 9 to 16, severe: 17 to 25

Secondary Outcome Measures

Name	Time	Method
Serum 25 (OH) D level	8 weeks	Vitamin D deficiency is defined as serum 25 (OH) D level\<20 μ g/L

Trial Locations

Locations (1)

SAHWenzhouMU; 🇨🇳 Wenzhou, Zhejiang, China