Ulcerative ColitisNCT05649462
Effect of Vitamin D Supplementation on Vedolizumab Response in Patients With Ulcerative Colitis
An observational study of Ulcerative Colitis and Vitamin D Deficiency, 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 ulcerative colitis (UC). The effects of vitD3 supplements on the efficacy of vidrecizumab in Chinese UC patients were retrospectively analyzed. Methods: Patients with moderate to severe UC were recorded. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Ulcerative Colitis, Vitamin D Deficiency, Vitamin D Supplement
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Jun 2022
- 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 UC
- Treated with Vedolizumab
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
Official title: Retrospective Analysis of the Effect of Vitamin D Supplementation on the Clinical Efficacy of Vedelizumab in Ulcerative Colitis Patients
It is uncertain whether vitD3 supplementation is beneficial for the remission of ulcerative colitis (UC). The effects of vitD3 supplements on the efficacy of vidrecizumab in Chinese UC patients were retrospectively analyzed. Methods: Patients with moderate to severe UC were recorded. These patients were initially treated with VDZ. VitD3 supplementation was defined as 400IU/d vitD3 supplementation during the first infusion of VDZ and continued throughout the follow-up period. Disease activity was assessed using the modified Mayo score.
- Medical subject headings
- Colitis, Ulcerative, Vitamin D Deficiency
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 described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25 (OH) D level
Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.
Measured: 30 weeks
disease activity
modified Mayo score，mild: 3 to 5, moderate: 6 to 10, severe: 11 to 12
Measured: 30 weeks
Secondary outcomes (1)
drug survival
Proportion of UC patients who continued to receive VDZ
Measured: 54 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Jan 2020
- Primary completion1 Nov 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- 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
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xia shenglong, Master, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649462
- Sponsor's protocol ID
- SAHoWMU-CR2022-07-27
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 14 Dec 2022
- 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 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Effect of Vitamin D Supplementation on the Clinical Efficacy of Vedelizumab in Ulcerative Colitis Patients
- ClinicalTrials.gov ID
- NCT05649462
- Acronym / sponsor ID
- SAHoWMU-CR2022-07-27
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 14 Dec 2022 (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 ulcerative colitis (UC). The effects of vitD3 supplements on the efficacy of vidrecizumab in Chinese UC patients were retrospectively analyzed. Methods: Patients with moderate to severe UC were recorded. These patients were initially treated with VDZ. VitD3 supplementation was defined as 400IU/d vitD3 supplementation during the first infusion of VDZ and continued throughout the follow-up period. Disease activity was assessed using the modified Mayo score.
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 | – | – |
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 UC
- Treated with Vedolizumab
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: 30 weeks
Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.
disease activity
Time frame: 30 weeks
modified Mayo score，mild: 3 to 5, moderate: 6 to 10, severe: 11 to 12
1 secondary outcome
drug survival
Time frame: 54 week
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 14 Dec 2022.
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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.
Xia shenglong, Master 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 Ulcerative Colitis and Vitamin D Deficiency, 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 14 Dec 2022. 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: 30 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 14 Dec 2022.