UstekinumabNCT05867784
Effect of Vitamin D Supplementation on the Efficacy of Ustekinumab in the Treatment of Crohn's Disease
An observational study of Ustekinumab and Vitamin D Supplementation, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Ustekinumab, Vitamin D Supplementation, Crohn's Disease
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2021to 15 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- Child, Adult, Older adult
Study population: Chinese
Who may be able to join
- moderate-to-severe CD
- Treated with Ustekinumab
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Serum 25 (OH) D level
Vitamin D deficiency is defined as serum 25 (OH) D level<20 μ g/L
Measured: 24 weeks
disease activity
Harvey Bradshaw Index，mild: 0 to 8, moderate: 9 to 16, severe: 17 to 25
Measured: 24weeks
Secondary outcomes (1)
Serum 25 (OH) D level
Vitamin D deficiency is defined as serum 25 (OH) D level<20 μ g/L
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start30 Apr 2021
- Primary completion15 Feb 2022
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UstekinumabStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Jiang, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867784
- Sponsor's protocol ID
- SAHoWMU-CR2023-01-203
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on the Efficacy of Ustekinumab in the Treatment of Crohn's Disease
- ClinicalTrials.gov ID
- NCT05867784
- Acronym / sponsor ID
- SAHoWMU-CR2023-01-203
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (2 listed)
- moderate-to-severe CD
- Treated with Ustekinumab
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum 25 (OH) D level
Time frame: 24 weeks
Vitamin D deficiency is defined as serum 25 (OH) D level<20 μ g/L
disease activity
Time frame: 24weeks
Harvey Bradshaw Index，mild: 0 to 8, moderate: 9 to 16, severe: 17 to 25
1 secondary outcome
Serum 25 (OH) D level
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Jiang principal investigator
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ustekinumab and Vitamin D Supplementation, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25 (OH) D level (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.