Overview

Observation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene Polymorphism

Status:
Not yet recruiting
Trial end date:
2021-03-01
Target enrollment:
0
Participant gender:
All
Summary
Aims:Prospectively observe the effects of Vitamin D drops supplementation on the chronic course of ulcerative colitis patients, analyze whether the effect of Vitamin D drops on UC 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 UC patients in the future. Design：It is a prospective cohort study. Investigators include a total of 100 participants with UC 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 in the 3rd, 6th, 9th, and 12th months, 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 UC participants, improve the condition of UC participants,relationship with Fok I gene polymorphism，and analyze the effects of Vitamin D drops on participants with UC is affected by factors such as disease site, disease activity, and treatment.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Second Affiliated Hospital of Wenzhou Medical University
Treatments:
Ergocalciferols
Vitamin D
Vitamins
Criteria
Inclusion Criteria:

- Clearly diagnosed patients with UC

- 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