Crohn's DiseaseEarly Phase 1NCT04308850
Exploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D Deficiency
A Early Phase 1 study testing Vitamin D drops in people with Crohn's Disease and Vitamin D Deficiency, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Aims:Prospectively observe the effects of Vitamin D drops supplementation on the chronic course of Crohn's disease patients, analyze whether the effect of Vitamin D drops on CD patients is affected by factors such as disease site, disease activity, treatment, etc.Exploring the relationship between Fok I gene… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease, Vitamin D Deficiency, Vitamin D Supplement
- What is being tested?
- Vitamin D drops
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2020to Apr 2021
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clearly diagnosed patients with CD
- Vitamin D deficiency (<= 20ng / ml)
Who cannot join
- Pregnancy, lactation
- Liver and kidney insufficiency
- Co-morbid with other autoimmune diseases
- Use antiepileptic drugs or drugs metabolized by liver cytochrome P450 enzymes
- Vitamin D level is normal or high
- Receiving infliximab treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D Deficiency，a Prospective Cohort Study
Aims:Prospectively observe the effects of Vitamin D drops supplementation on the chronic course of Crohn's disease patients, analyze whether the effect of Vitamin D drops on CD patients is affected by factors such as disease site, disease activity, treatment, etc.Exploring the relationship between Fok I gene polymorphism and the efficacy of vitamin D supplementation. Provide a certain theoretical basis for "precision treatment" for CD patients in the future.
Design：It is a prospective cohort study. Investigators include a total of 60 participants with CD according to the inclusion and exclusion criteria, and divide them into two groups to assess their initial disease activity and detect related indicators. At the same time，investigators detect the Fok I gene polymorphism in all participants.One group is given Vitamin D drops 400IU per day orally, and the control group do not intervene. Participants' disease activity is assessed at baseline and related indicators are determined. The disease activity is re-evaluated at 2, 6, 14, 22, 30, and 38 weeks, and the serum indexes are re-evaluated.Investigators use statistical methods to analyze whether Vitamin D drops supplementation treatment can increase the serum 25 (OH) D level of CD participants who are treated with infliximab, improve the condition of CD participants,relationship with Fok I gene polymorphism，and analyze the effects of Vitamin D drops on participants with CD is affected by factors such as disease site, disease activity, and treatment.
Read the detailed description
- The research can be started only after approval by the Medical Ethics Committee of the Second Affiliated Hospital of Wenzhou Medical University.
- According to the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease" formulated by the Beijing Conference in 2018 as a standard, patients with clear diagnosis of CD are collected. Other diagnostic criterions include vitamin D deficiency (<= 20ng / ml) and treatment with infliximab. Exclusion criteria include pregnancy, breastfeeding, liver and kidney dysfunction, concurrent autoimmune diseases, and use of antiepileptic drugs or drugs metabolized by liver cytochrome P450 enzymes.
- Assess disease activity of CD participants based on the "Simplified Crohn's disease Activity Score".
- General information about participants with CD is collected.
- Detection of Fok I gene polymorphism using Snapshot technology.
- The level of serum 25 (OH) D of participants is detected.
- Serum C-reactive protein, erythrocyte sedimentation rate, albumin, calcium and phosphorus levels are measured.
- Develop a treatment plan for all participants.
- Participants are divided into two groups, one group is given oral vitamin D drops 400IU/ d, and the other group do not intervene.
- The disease activity is re-evaluated at 2, 6, 14, 22, 30, and 38 weeks, and the above serum indexes are re-evaluated.
- Follow-up for 38 weeks. By comparing the above indicators, observe that in the Han population:
- Can Vitamin D drops supplementation increase serum 25 (OH) D levels in patients with CD who are treated with infliximab?
- Can Vitamin D drops supplementation improve the condition of patients with CD who are treated with infliximab?
- Whether Fok I gene polymorphism affect the efficacy of Vitamin D drops supplementation therapy?
- Whether the effects of Vitamin D drops on CD patients who are treated with infliximab is affected by factors such as disease site, disease activity, treatment, etc ..
- Through statistical analysis, comprehensive analysis of the effectiveness and safety of Vitamin D drops supplementation in Han patients with CD who are treated with infliximab，and its relationship with Fok I gene polymorphism, providing a theoretical basis for further "precise treatment" intervention in inflammatory bowel disease.
- Conditions
- Crohn's Disease, Vitamin D Deficiency, Vitamin D Supplement
- Being tested
- Vitamin D drops
- 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.
Vitamin D dropsDrug
Vitamin D-deficient CD patients are divided into two groups, one group is given orally with Vitamin D drops 400IU / d, while the other group do not interfere.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D drops | Experimental | This group of patients are going to supplemented with Vitamin D drops 400IU / d orally. Receives: Drug: Vitamin D drops |
| Control | No intervention | The other group do not interfere. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants
Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants can reflect whether it is related to the severity of the disease and how much relevance.
Measured: 9month
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: 9month
Secondary outcomes (3)
Blood calcium and phosphorus level
Monitoring serum calcium and phosphorus levels to prevent toxic side effects.
Measured: 9month
erythrocyte sedimentation rate
ESR can be used to reflect the degree of inflammation in the body.
Measured: 9month
Concentration of C-reactive protein in participants
Concentration of C-reactive protein can be used to reflect the degree of inflammation in the human body.
Measured: 9month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study startOct 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xia sheng long, Master, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308850
- Sponsor's protocol ID
- SAHoWMU-CR2020-01-104
- Status last verified
- Oct 2020
- First submitted
- 24 Feb 2020
- Last updated
- 14 Oct 2020
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D Deficiency，a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04308850
- Acronym / sponsor ID
- SAHoWMU-CR2020-01-104
- Conditions
- Crohn's Disease, Vitamin D Deficiency, Vitamin D Supplement
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 16 Mar 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.
Aims:Prospectively observe the effects of Vitamin D drops supplementation on the chronic course of Crohn's disease patients, analyze whether the effect of Vitamin D drops on CD patients is affected by factors such as disease site, disease activity, treatment, etc.Exploring the relationship between Fok I gene polymorphism and the efficacy of vitamin D supplementation. Provide a certain theoretical basis for "precision treatment" for CD patients in the future.
Design：It is a prospective cohort study. Investigators include a total of 60 participants with CD according to the inclusion and exclusion criteria, and divide them into two groups to assess their initial disease activity and detect related indicators. At the same time，investigators detect the Fok I gene polymorphism in all participants.One group is given Vitamin D drops 400IU per day orally, and the control group do not intervene. Participants' disease activity is assessed at baseline and related indicators are determined. The disease activity is re-evaluated at 2, 6, 14, 22, 30, and 38 weeks, and the serum indexes are re-evaluated.Investigators use statistical methods to analyze whether Vitamin D drops supplementation treatment can increase the serum 25 (OH) D level of CD participants who are treated with infliximab, improve the condition of CD participants,relationship with Fok I gene polymorphism，and analyze the effects of Vitamin D drops on participants with CD is affected by factors such as disease site, disease activity, and treatment.
Detailed description
- The research can be started only after approval by the Medical Ethics Committee of the Second Affiliated Hospital of Wenzhou Medical University.
- According to the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease" formulated by the Beijing Conference in 2018 as a standard, patients with clear diagnosis of CD are collected. Other diagnostic criterions include vitamin D deficiency (<= 20ng / ml) and treatment with infliximab. Exclusion criteria include pregnancy, breastfeeding, liver and kidney dysfunction, concurrent autoimmune diseases, and use of antiepileptic drugs or drugs metabolized by liver cytochrome P450 enzymes.
- Assess disease activity of CD participants based on the "Simplified Crohn's disease Activity Score".
- General information about participants with CD is collected.
- Detection of Fok I gene polymorphism using Snapshot technology.
- The level of serum 25 (OH) D of participants is detected.
- Serum C-reactive protein, erythrocyte sedimentation rate, albumin, calcium and phosphorus levels are measured.
- Develop a treatment plan for all participants.
- Participants are divided into two groups, one group is given oral vitamin D drops 400IU/ d, and the other group do not intervene.
- The disease activity is re-evaluated at 2, 6, 14, 22, 30, and 38 weeks, and the above serum indexes are re-evaluated.
- Follow-up for 38 weeks. By comparing the above indicators, observe that in the Han population:
- Can Vitamin D drops supplementation increase serum 25 (OH) D levels in patients with CD who are treated with infliximab?
- Can Vitamin D drops supplementation improve the condition of patients with CD who are treated with infliximab?
- Whether Fok I gene polymorphism affect the efficacy of Vitamin D drops supplementation therapy?
- Whether the effects of Vitamin D drops on CD patients who are treated with infliximab is affected by factors such as disease site, disease activity, treatment, etc ..
- Through statistical analysis, comprehensive analysis of the effectiveness and safety of Vitamin D drops supplementation in Han patients with CD who are treated with infliximab，and its relationship with Fok I gene polymorphism, providing a theoretical basis for further "precise treatment" intervention in inflammatory bowel disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D drops | Experimental | Drug: Vitamin D dropsThis group of patients are going to supplemented with Vitamin D drops 400IU / d orally. |
| Control | No intervention | –The other group do not interfere. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clearly diagnosed patients with CD
- Vitamin D deficiency (<= 20ng / ml)
Key exclusion criteria (6 listed)
- Pregnancy, lactation
- Liver and kidney insufficiency
- Co-morbid with other autoimmune diseases
- Use antiepileptic drugs or drugs metabolized by liver cytochrome P450 enzymes
- Vitamin D level is normal or high
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 |
|---|---|---|
| Vitamin D dropsVitamin D-deficient CD patients are divided into two groups, one group is given orally with Vitamin D drops 400IU / d, while the other group do not interfere. | Drug | Vitamin D drops |
Primary outcome
Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants
Time frame: 9month
Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants can reflect whether it is related to the severity of the disease and how much relevance.
Serum 25 (OH) D level
Time frame: 9month
Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.
3 secondary outcomes
Blood calcium and phosphorus level
Time frame: 9month
erythrocyte sedimentation rate
Time frame: 9month
Concentration of C-reactive protein in participants
Time frame: 9month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- 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, 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?
A Early Phase 1 study testing Vitamin D drops in people with Crohn's 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Oct 2020. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xia sheng long, Master (0086-15868532956, xsl1989@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants (time frame: 9month). 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 Oct 2020.