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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

2020年3月12日 更新者：Second Affiliated Hospital of Wenzhou Medical University

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

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.

研究概览

地位

未知

条件

干预/治疗

详细说明

  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.

研究类型

介入性

注册 (预期的)

100

阶段

  • 第一阶段早期

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Zhejiang
      • Wenzhou、Zhejiang、中国
        • SAHWenzhouMU

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：控制
另一组不干涉。
实验性的：维生素D滴剂
本组患者准备口服补充维生素D滴剂400IU/d。
药品：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants
大体时间：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.
1 year
Serum 25 (OH) D level
大体时间：1year
Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status
1year

次要结果测量

结果测量
措施说明
大体时间
红细胞沉降率
大体时间：1年
ESR可以用来反映体内炎症的程度。
1年
Blood calcium and phosphorus
大体时间：1year
Monitoring serum calcium and phosphorus levels to prevent toxic side effects.
1year
Concentration of C-reactive protein in participants
大体时间：1year
Concentration of C-reactive protein can be used to reflect the degree of inflammation in the human body.
1year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Second Affiliated Hospital of Wenzhou Medical University

调查人员

  • 首席研究员：Jiang yi, PhD、Second Affiliated Hospital of Wenzhou Medical University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2020年3月1日

初级完成 (预期的)

2021年3月1日

研究完成 (预期的)

2021年3月1日

研究注册日期

首次提交

2020年2月24日

首先提交符合 QC 标准的

2020年3月12日

首次发布 (实际的)

2020年3月16日

研究记录更新

最后更新发布 (实际的)

2020年3月16日

上次提交的符合 QC 标准的更新

2020年3月12日

最后验证

2020年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • SAHoWMU-CR2017-01-121

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

Data sets will be made available on relevant requests and in accordance with journal guidelines when publishing results from this study.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

维生素 D 缺乏症的临床试验

Vitamin D drops的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Congo, DR of

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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