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

Early Phase 1

• Conditions: Ulcerative Colitis; Vitamin D Deficiency; Vitamin D Supplement
• Interventions: Drug: Vitamin D drops

• Registration Number: NCT04309058
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief 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.

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 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.

3. Assess disease activity of UC participants based on the "Moya score".

4. General information about participants with UC 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 in the 3rd, 6th, 9th, and 12th months, and the above serum indexes are re-evaluated.

11. Follow-up for 12 months. 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 UC?

2. Can Vitamin D drops supplementation improve the condition of patients with UC?

3. Whether Fok I gene polymorphism affect the efficacy of Vitamin D drops supplementation therapy?

4. Whether the effects of Vitamin D drops on UC patients 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 UC, and its relationship with Fok I gene polymorphism, providing a theoretical basis for further "precise treatment" intervention in inflammatory bowel disease.

Study Timeline

• Study First Submitted: 2020-02-24
• Status Verified: 2020-03
• Study Start: 2020-03
• Study First Submitted QC: 2020-03-12
• Last Update Submitted: 2020-03-12
• Study First Posted: 2020-03-16
• Last Update Posted: 2020-03-16
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Serum 25 (OH) D level	1year	Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status
Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Blood calcium and phosphorus	1year	Monitoring serum calcium and phosphorus levels to prevent toxic side effects.
erythrocyte sedimentation rate	1year	ESR can be used to reflect the degree of inflammation in the body.
Concentration of C-reactive protein in participants	1year	Concentration of C-reactive protein can be used to reflect the degree of inflammation in the human body.

Trial Locations

Locations (1)

SAHWenzhouMU; 🇨🇳 Wenzhou, Zhejiang, China