Crohn's DiseaseEarly Phase 1NCT04276636
Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency
A Early Phase 1 study testing Caltrate Pill 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 Caltrate supplementation on the chronic course of Crohn's disease patients, analyze whether the effect of Caltrate on CD patients is affected by factors such as disease site, disease activity, treatment, etc.Provide a certain theoretical basis for "precision treatment" for CD… 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?
- Caltrate Pill
- 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 Mar 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency，a Prospective Cohort Study
Aims:Prospectively observe the effects of Caltrate supplementation on the chronic course of Crohn's disease patients, analyze whether the effect of Caltrate on CD patients is affected by factors such as disease site, disease activity, treatment, etc.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 Vitamin D Gene gene polymorphisms in all participants.One group is given Caltrate 0.6g per day orally, and the control group do not intervene. After 12 months, re-evaluate the disease activity and retest the relevant indicators, and use statistical methods to analyze whether Caltrate supplementation treatment can increase the serum 25 (OH) D level of CD participants, improve the condition of CD participants,relationship with Vitamin D Gene Polymorphism，and analyze the effect of Caltrate 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. Exclusion criteria included 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 VDR gene polymorphisms using Snapshot technology.
- Serum C-reactive protein, erythrocyte sedimentation rate, white blood cells, albumin, creatinine, alanine aminotransferase, calcium and phosphorus levels are measured.
- The level of serum 25 (OH) D of participants is detected.
- Develop a treatment plan for participants.
- Participants are divided into two groups, one group is given oral Caltrate 0.6g / d, and the other group did not intervene.
- The above serum indicators are re-measured in the 12th month, and the condition of CD participants is also evaluated.
- Follow-up for 12 months. By comparing the above indicators, observe that in the Han population:
- Can Caltrate supplementation increase serum 25 (OH) D levels in patients with CD?
- Can Caltrate supplementation improve the condition of patients with CD?
- whether vitamin D gene polymorphisms affect the efficacy of Caltrate supplementation therapy?
- Analyze whether the effect of Caltrate on CD patients is affected by factors such as disease site, disease activity, treatment, etc ..
- Through statistical analysis, comprehensive analysis of the effectiveness and safety of Caltrate supplementation in Han patients with CD, and its relationship with vitamin D gene polymorphisms, 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
- 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
Vitamin D-deficient CD patients are divided into two groups, one group is given orally with Caltrate Pill 0.6 g / d, while the other group do not interfere.
| Study group | Role | What they receive |
|---|---|---|
| Caltrate | Experimental | This group of patients are going to supplemented with Caltrate 0.6 g / d orally. Receives: Drug: Caltrate Pill |
| 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.
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: 1year
Secondary outcomes (3)
White blood cell count
White blood cell count can be used to reflect the degree of inflammation in the body
Measured: 1year
erythrocyte sedimentation rate
ESR can be used to reflect the degree of inflammation in the body.
Measured: 1year
C-reactive protein.
C-reactive protein can be used to reflect the degree of inflammation in the human body
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study startOct 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 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 Xia long, Master, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276636
- Sponsor's protocol ID
- SAHoWMU-CR2020-01-102
- Status last verified
- Oct 2020
- First submitted
- 17 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 Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency，a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04276636
- Acronym / sponsor ID
- SAHoWMU-CR2020-01-102
- 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
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 19 Feb 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 Caltrate supplementation on the chronic course of Crohn's disease patients, analyze whether the effect of Caltrate on CD patients is affected by factors such as disease site, disease activity, treatment, etc.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 Vitamin D Gene gene polymorphisms in all participants.One group is given Caltrate 0.6g per day orally, and the control group do not intervene. After 12 months, re-evaluate the disease activity and retest the relevant indicators, and use statistical methods to analyze whether Caltrate supplementation treatment can increase the serum 25 (OH) D level of CD participants, improve the condition of CD participants,relationship with Vitamin D Gene Polymorphism，and analyze the effect of Caltrate 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. Exclusion criteria included 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 VDR gene polymorphisms using Snapshot technology.
- Serum C-reactive protein, erythrocyte sedimentation rate, white blood cells, albumin, creatinine, alanine aminotransferase, calcium and phosphorus levels are measured.
- The level of serum 25 (OH) D of participants is detected.
- Develop a treatment plan for participants.
- Participants are divided into two groups, one group is given oral Caltrate 0.6g / d, and the other group did not intervene.
- The above serum indicators are re-measured in the 12th month, and the condition of CD participants is also evaluated.
- Follow-up for 12 months. By comparing the above indicators, observe that in the Han population:
- Can Caltrate supplementation increase serum 25 (OH) D levels in patients with CD?
- Can Caltrate supplementation improve the condition of patients with CD?
- whether vitamin D gene polymorphisms affect the efficacy of Caltrate supplementation therapy?
- Analyze whether the effect of Caltrate on CD patients is affected by factors such as disease site, disease activity, treatment, etc ..
- Through statistical analysis, comprehensive analysis of the effectiveness and safety of Caltrate supplementation in Han patients with CD, and its relationship with vitamin D gene polymorphisms, 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 |
|---|---|---|
| Caltrate | Experimental | Drug: Caltrate PillThis group of patients are going to supplemented with Caltrate 0.6 g / 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 (5 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 |
|---|---|---|
| Caltrate PillVitamin D-deficient CD patients are divided into two groups, one group is given orally with Caltrate Pill 0.6 g / d, while the other group do not interfere. | Drug | Caltrate |
Primary outcome
Serum 25 (OH) D level
Time frame: 1year
Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.
3 secondary outcomes
White blood cell count
Time frame: 1year
erythrocyte sedimentation rate
Time frame: 1year
C-reactive protein.
Time frame: 1year
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 Xia 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 Caltrate Pill 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 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: 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?
Serum 25 (OH) D level (time frame: 1year). 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.