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

May 18, 2023 updated by: Second Affiliated Hospital of Wenzhou Medical University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • SAHWenzhouMU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Chinese

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum 25 (OH) D level
Time Frame: 8 weeks
Vitamin D deficiency is defined as serum 25 (OH) D level<20 μ g/L
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2021

Primary Completion (Actual)

February 15, 2022

Study Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2023-01-203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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