Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Crohn's Disease
  • Vitamin D Deficiency
  • Vitamin D Supplement
Type
Interventional
Phase
Early Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT04308850
Collaborators
Not Provided
Investigators
Principal Investigator: Xia sheng long, Master Second Affiliated Hospital of Wenzhou Medical University