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

NCT ID: NCT04309058

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2021-03-31

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.

Conditions

Ulcerative Colitis; Vitamin D Deficiency; Vitamin D Supplement

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin D drops

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

Group Type: EXPERIMENTAL

Vitamin D drops

Intervention Type: DRUG

Vitamin D-deficient UC patients are divided into two groups, one group is given orally with Vitamin D drops 400IU / d, while the other group do not interfere.

Control

The other group do not interfere.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin D drops

Vitamin D-deficient UC patients are divided into two groups, one group is given orally with Vitamin D drops 400IU / d, while the other group do not interfere.

Intervention Type: DRUG

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiang yi, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Wenzhou Medical University

Locations

SAHWenzhouMU

Wenzhou, Zhejiang, China

Countries

China

Central Contacts

Jiang yi, PhD

Role: CONTACT

wzjiangyi@yeah.net

0086-13676715542

Other Identifiers

SAHoWMU-CR2017-01-121

Identifier Type: -

Identifier Source: org_study_id