Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Ulcerative Colitis
  • 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 UC are collected.Other diagnostic criteria include Vitamin D deficiency (<= 20ng / ml). 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 UC participants based on the "Moya score". General information about participants with UC 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 in the 3rd, 6th, 9th, and 12th months, and the above serum indexes are re-evaluated. Follow-up for 12 months. 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 UC? Can Vitamin D drops supplementation improve the condition of patients with UC? Whether Fok I gene polymorphism affect the efficacy of Vitamin D drops supplementation therapy? Whether the effects of Vitamin D drops on UC patients 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 UC, and its relationship with Fok I gene polymorphism, providing a theoretical basis for further "precise treatment" intervention in inflammatory bowel disease.

Tracking Information

NCT #
NCT04309058
Collaborators
Not Provided
Investigators
Principal Investigator: Jiang yi, PhD Second Affiliated Hospital of Wenzhou Medical University