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

Sponsor
Second Affiliated Hospital of Wenzhou Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05867784
Collaborator
(none)
80
Enrollment
1
Location
22.5
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Effect of Vitamin D Supplementation on the Efficacy of Ustekinumab in the Treatment of Crohn's Disease
    Actual Study Start Date :
    Apr 30, 2021
    Actual Primary Completion Date :
    Feb 15, 2022
    Actual Study Completion Date :
    Mar 15, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Serum 25 (OH) D level [24 weeks]

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

    2. disease activity [24weeks]

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

    Secondary Outcome Measures

    1. Serum 25 (OH) D level [8 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 65 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SAHWenzhouMU Wenzhou Zhejiang China 325000

    Sponsors and Collaborators

    • Second Affiliated Hospital of Wenzhou Medical University

    Investigators

    • Principal Investigator: Yi Jiang, Second Affiliated Hospital of Wenzhou Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital of Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT05867784
    Other Study ID Numbers:
    • SAHoWMU-CR2023-01-203
    First Posted:
    May 22, 2023
    Last Update Posted:
    May 22, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Crohn Disease

    Study Results

    No Results Posted as of May 22, 2023