Effect of Vitamin D Supplementation on the Efficacy of Us... | NCT05867784

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

NCT05867784

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Status

Completed

Last Update Posted

May 22, 2023Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Ustekinumab
Vitamin D Supplementation
Crohn's Disease
Clinical Efficacy

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2021Actual

Primary Completion Date

Feb 15, 2022Actual

Completion Date

Mar 15, 2023Actual

First Submitted Date

May 10, 2023

First Submission Date that Met QC Criteria

May 18, 2023

First Posted Date

May 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2023

Last Update Posted Date

May 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Chinese

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yi Jiang	Second Affiliated Hospital of Wenzhou Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SAHWenzhouMU		Wenzhou	Zhejiang	325000	China

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided