Crohn DiseaseNCT04606017
Effect of Vitamin D Supplementation on Infliximab Response in Patients With Crohn's Disease
An observational study of Crohn Disease and Vitamin D Deficiency, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Background: It remains uncertain whether vitD3 supplementation is beneficial for remission of Crohn's disease (CD). The influence of vitD3 supplementation on Infliximab (IFX) efficacy was retrospectively analyzed in Chinese CD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Vitamin D Deficiency, Vitamin D Supplement
- What is being tested?
- Caltrate Pill
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 1 Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese
Who may be able to join
- moderate-to-severe CD
- Treated with Infliximab
- bio-naïve at the time of diagnosis
Who cannot join
- had recent supplementation of vitD3
- had prior or concomitant use of other biologic agent, glucocorticoid and/or immunomodulators at the time of enrollment
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Vitamin D3 Supplementation on Infliximab Efficacy in Chinese Patients With Crohn's Disease: A Retrospective Cohort Study
Background: It remains uncertain whether vitD3 supplementation is beneficial for remission of Crohn's disease (CD). The influence of vitD3 supplementation on Infliximab (IFX) efficacy was retrospectively analyzed in Chinese CD patients. Methods: Patients with moderate-to-severe CD, who were bio-naïve and prescribed with IFX treatment for at least 54 weeks were recorded. VitD3 supplementation was defined as patients additionally took oral vitD3 (125 IU/d) within 3 days after the first infusion and persisted in the whole follow-up period. Disease activity was assessed using Harvey-Bradshaw Index (HBI). Serum cytokine profiles were quantitatively analyzed in a subset of all patients at baseline and 54-week after intervention.
- Conditions
- Crohn Disease, Vitamin D Deficiency, Vitamin D Supplement
- Being tested
- Caltrate Pill
- Medical subject headings
- Crohn Disease, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caltrate PillDrug
VitD3 supplementation was defined as patients additionally took oral vitD3 (125 IU/d) within 3 days after the first infusion and persisted in the whole follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Vitamain D | This group of patients were supplemented with 125IU/d Vitamin D Receives: Drug: Caltrate Pill | |
| Control | The other group did not receive the supplementation of 125IU/d Vitamin D |
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: 54 weeks
disease activity
CDAI evaluation
Measured: 54 weeks
Secondary outcomes (2)
the metabolism of calcium and phosphorus
serum levels calcium and phosphorus
Measured: 54 weeks
the expression profiles of Th-cell-related cytokines
Serum levels of IL-2, IL-4, IL-6, IL-10, TNF-α and IFN-γ
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Jan 2014
- Primary completion31 Dec 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies 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
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xia sheng long long, Master, Study director, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606017
- Sponsor's protocol ID
- SAHoWMU-CR2020-01-213
- Status last verified
- Apr 2021
- First submitted
- 25 Oct 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sets will be made available on relevant requests and in accordance with journal guidelines when publishing results from this study.
Publications
Xia SL, Min QJ, Shao XX, Lin DP, Ma GL, Wu H, Cao SG, Jiang Y. Influence of Vitamin D3 Supplementation on Infliximab Effectiveness in Chinese Patients With Crohn's Disease: A Retrospective Cohort Study. Front Nutr. 2021 Oct 22;8:739285. doi: 10.3389/fnut.2021.739285. eCollection 2021.
PubMed 34746207
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Vitamin D3 Supplementation on Infliximab Efficacy in Chinese Patients With Crohn's Disease: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04606017
- Acronym / sponsor ID
- SAHoWMU-CR2020-01-213
- Conditions
- Crohn Disease, Vitamin D Deficiency, Vitamin D Supplement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 28 Oct 2020 (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.
Background: It remains uncertain whether vitD3 supplementation is beneficial for remission of Crohn's disease (CD). The influence of vitD3 supplementation on Infliximab (IFX) efficacy was retrospectively analyzed in Chinese CD patients. Methods: Patients with moderate-to-severe CD, who were bio-naïve and prescribed with IFX treatment for at least 54 weeks were recorded. VitD3 supplementation was defined as patients additionally took oral vitD3 (125 IU/d) within 3 days after the first infusion and persisted in the whole follow-up period. Disease activity was assessed using Harvey-Bradshaw Index (HBI). Serum cytokine profiles were quantitatively analyzed in a subset of all patients at baseline and 54-week after intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamain D | – | Drug: Caltrate PillThis group of patients were supplemented with 125IU/d Vitamin D |
| Control | – | –The other group did not receive the supplementation of 125IU/d Vitamin D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (3 listed)
- moderate-to-severe CD
- Treated with Infliximab
- bio-naïve at the time of diagnosis
Key exclusion criteria (5 listed)
- had recent supplementation of vitD3
- had prior or concomitant use of other biologic agent, glucocorticoid and/or immunomodulators at the time of enrollment
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caltrate PillVitD3 supplementation was defined as patients additionally took oral vitD3 (125 IU/d) within 3 days after the first infusion and persisted in the whole follow-up period. | Drug | Vitamain D |
Primary outcome
Serum 25 (OH) D level
Time frame: 54 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: 54 weeks
CDAI evaluation
2 secondary outcomes
the metabolism of calcium and phosphorus
Time frame: 54 weeks
the expression profiles of Th-cell-related cytokines
Time frame: 54 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 28 Apr 2021.
- Derived from this study: PubMed 34746207Xia SL, Min QJ, Shao XX, Lin DP, Ma GL, Wu H, Cao SG, Jiang Y. Influence of Vitamin D3 Supplementation on Infliximab Effectiveness in Chinese Patients With Crohn's Disease: A Retrospective Cohort Study. Front Nutr. 2021 Oct 22;8:739285. doi: 10.3389/fnut.2021.739285. eCollection 2021.
- Individual participant dataSharing planned: Undecided. Data sets will be made available on relevant requests and in accordance with journal guidelines when publishing results from this study.
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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 sheng long long, Master study director
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 Crohn Disease 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 3 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 28 Apr 2021. 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: 54 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?
On the ClinicalTrials.gov record for NCT04606017, which also lists 1 linked publication.
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 28 Apr 2021.