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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

Primary Purpose

Ulcerative Colitis, Vitamin D Deficiency, Vitamin D Supplement

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Vitamin D drops
Sponsored by
Second Affiliated Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • SAHWenzhouMU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vitamin D drops

Control

Arm Description

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

The other group do not interfere.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2020
Last Updated
March 12, 2020
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04309058
Brief Title
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
Official Title
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,a Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2020 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Vitamin D Deficiency, Vitamin D Supplement

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D drops
Arm Type
Experimental
Arm Description
This group of patients are going to supplemented with Vitamin D drops 400IU / d orally.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The other group do not interfere.
Intervention Type
Drug
Intervention Name(s)
Vitamin D drops
Intervention Description
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.
Primary Outcome Measure Information:
Title
Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants
Description
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.
Time Frame
1 year
Title
Serum 25 (OH) D level
Description
Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status
Time Frame
1year
Secondary Outcome Measure Information:
Title
Blood calcium and phosphorus
Description
Monitoring serum calcium and phosphorus levels to prevent toxic side effects.
Time Frame
1year
Title
erythrocyte sedimentation rate
Description
ESR can be used to reflect the degree of inflammation in the body.
Time Frame
1year
Title
Concentration of C-reactive protein in participants
Description
Concentration of C-reactive protein can be used to reflect the degree of inflammation in the human body.
Time Frame
1year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang yi, PhD
Phone
0086-13676715542
Email
wzjiangyi@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang yi, PhD
Organizational Affiliation
Second Affiliated Hospital of Wenzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SAHWenzhouMU
City
Wenzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data sets will be made available on relevant requests and in accordance with journal guidelines when publishing results from this study.

Learn more about this trial

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

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