Exploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D Deficiency
NCT ID: NCT04308850
Last Updated: 2020-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
60 participants
INTERVENTIONAL
2020-10-31
2021-04-30
Brief Summary
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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.
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Detailed Description
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2. 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.
3. Assess disease activity of CD participants based on the "Simplified Crohn's disease Activity Score".
4. General information about participants with CD is collected.
5. Detection of Fok I gene polymorphism using Snapshot technology.
6. The level of serum 25 (OH) D of participants is detected.
7. Serum C-reactive protein, erythrocyte sedimentation rate, albumin, calcium and phosphorus levels are measured.
8. Develop a treatment plan for all participants.
9. Participants are divided into two groups, one group is given oral vitamin D drops 400IU/ d, and the other group do not intervene.
10. The disease activity is re-evaluated at 2, 6, 14, 22, 30, and 38 weeks, and the above serum indexes are re-evaluated.
11. Follow-up for 38 weeks. By comparing the above indicators, observe that in the Han population:
1. Can Vitamin D drops supplementation increase serum 25 (OH) D levels in patients with CD who are treated with infliximab?
2. Can Vitamin D drops supplementation improve the condition of patients with CD who are treated with infliximab?
3. Whether Fok I gene polymorphism affect the efficacy of Vitamin D drops supplementation therapy?
4. 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 ..
12. 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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vitamin D drops
This group of patients are going to supplemented with Vitamin D drops 400IU / d orally.
Vitamin D drops
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.
Control
The other group do not interfere.
No interventions assigned to this group
Interventions
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Vitamin D drops
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.
Eligibility Criteria
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Inclusion Criteria
* Vitamin D deficiency (\<= 20ng / ml)
Exclusion Criteria
* 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
ALL
Yes
Sponsors
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Second Affiliated Hospital of Wenzhou Medical University
OTHER
Responsible Party
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Principal Investigators
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Xia sheng long, Master
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital of Wenzhou Medical University
Locations
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SAHWenzhouMU
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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SAHoWMU-CR2020-01-104
Identifier Type: -
Identifier Source: org_study_id
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