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Exploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D Deficiency

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Clearly diagnosed patients with CD.
  • - Vitamin D deficiency (<= 20ng / ml)

    Exclusion Criteria:

    - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04308850
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Second Affiliated Hospital of Wenzhou Medical University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Xia sheng long, Master
Principal Investigator Affiliation Second Affiliated Hospital of Wenzhou Medical University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Crohn's Disease, Vitamin D Deficiency, Vitamin D Supplement
Additional Details

1. The research can be started only after approval by the Medical Ethics Committee of the Second Affiliated Hospital of Wenzhou Medical University. 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.

Arms & Interventions

Arms

Experimental: Vitamin D drops

This group of patients are going to supplemented with Vitamin D drops 400IU / d orally.

No Intervention: Control

The other group do not interfere.

Interventions

Drug: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

SAHWenzhouMU, Wenzhou, Zhejiang, China

Status

Address

SAHWenzhouMU

Wenzhou, Zhejiang, 325000

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