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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-30

Study Completion Date

2023-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Vitamin D Supplementation on Infliximab Response in Patients With Crohn's Disease

NCT04606017

Crohn Disease Vitamin D Deficiency Vitamin D Supplement

COMPLETED

Exploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D Deficiency

NCT04308850

Crohn's Disease Vitamin D Deficiency Vitamin D Supplement

UNKNOWN EARLY_PHASE1

Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy?

NCT03718182

Crohn Disease Vitamin D Deficiency

UNKNOWN PHASE4

Preliminary Clinical Study on the Effect of L-ornithine on the Efficacy of Ustekinumab in Patients With Crohn's Disease

NCT06455267

Mild to Severe Crohns Disease

RECRUITING NA

The Clinical Efficacy and Influence Factors of Individualized Treatment of Ustekinumab in Crohn's Disease

NCT06785493

IBD (Inflammatory Bowel Disease)

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ustekinumab Vitamin D Supplementation Crohn's Disease Clinical Efficacy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

supplementary group

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

No interventions assigned to this group

non-supplementary group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No