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

NCT05867784 | Completed

• 1 other identifier: SAHoWMU-CR2023-01-203
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Ustekinumab; Vitamin D Supplementation; Crohn's Disease; Clinical Efficacy

Outcome Measures

Primary Outcomes (2)

• Serum 25 (OH) D level

  Vitamin D deficiency is defined as serum 25 (OH) D level\<20 μ g/L

  24 weeks

• disease activity

  Harvey Bradshaw Index，mild: 0 to 8, moderate: 9 to 16, severe: 17 to 25

  24weeks

Secondary Outcomes (1)

• Serum 25 (OH) D level

  8 weeks

Study Arms (2)

supplementary group

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

non-supplementary group

not take vitamin D supplementation (400 IU/day) during VDZ treatment

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 CD
• Treated with Ustekinumab

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

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Yi Jiang

  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: May 10, 2023
• First Posted: May 22, 2023
• Study Start: April 30, 2021
• Primary Completion: February 15, 2022
• Study Completion: March 15, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

CN (1)