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

• ClinicalTrials.gov Identifier: NCT04308850
• Recruitment Status: Unknown
• First Posted: March 16, 2020
• Last Update Posted: October 14, 2020
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Information provided by (Responsible Party): Second Affiliated Hospital of Wenzhou Medical University

Tracking Information

• First Submitted Date: February 24, 2020
• First Posted Date: March 16, 2020
• Last Update Posted Date: October 14, 2020
• Estimated Study Start Date: October 2020
• Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 12, 2020)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 12, 2020)

• Blood calcium and phosphorus level [ Time Frame: 9month ]
  Monitoring serum calcium and phosphorus levels to prevent toxic side effects.
• erythrocyte sedimentation rate [ Time Frame: 9month ]
  ESR can be used to reflect the degree of inflammation in the body.
• Concentration of C-reactive protein in participants [ Time Frame: 9month ]
  Concentration of C-reactive protein can be used to reflect the degree of inflammation in the human body.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Brief 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 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

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.

• Study Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Crohn's Disease
• Vitamin D Deficiency
• Vitamin D Supplement

Intervention

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.

Study Arms

• Experimental: Vitamin D drops
  This group of patients are going to supplemented with Vitamin D drops 400IU / d orally.
  Intervention: Drug: Vitamin D drops
• No Intervention: Control
  The other group do not interfere.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 12, 2020): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2021
• Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04308850
• Other Study ID Numbers: SAHoWMU-CR2020-01-104
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: Data sets will be made available on relevant requests and in accordance with journal guidelines when publishing results from this study.

• Current Responsible Party: Second Affiliated Hospital of Wenzhou Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Xia sheng long, Master; Second Affiliated Hospital of Wenzhou Medical University

• PRS Account: Second Affiliated Hospital of Wenzhou Medical University
• Verification Date: October 2020