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临床试验/NCT04354207
NCT04354207Unknown不适用

Comparative Study of Vitamin D and Its Receptor Gene Polymorphisms in Lithuanian, Latvian, and Taiwanese Children and Adults With Atopic Dermatitis and Asthma

Lithuanian University of Health Sciences1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Vitamin D level in serum in patients with atopic dermatitis, asthma and healthy individuals from Lithuania, Latvia and Taiwan

研究概览

简要总结

The role of vitamin D is well known in calcium and phosphate homeostasis; however, in addition to traditional functions, vitamin D has an important role in pathogenesis of different allergic diseases, such as asthma, atopic dermatitis (AD), and food allergy. There are evidences that lower cord blood vitamin D status is observed in infants with eczema. More-over, vitamin D level is decreased in subjects with asthma. One of the most important functions of vitamin D is to modulate the immune system response, both innate and adaptive, by suppressing Th2-type response and increasing natural killer cells. Vitamin D induces a higher level of IL-10, which is known as anti-inflammatory cytokine. Other studies have shown that vitamin D contributes to the conversion of CD4+ T cells to T regulatory cells. Recent studies showed that higher serum 25-hydroxyvitamin D level was associated with a reduced risk of asthma exacerbation and hospitalization. Vitamin D can enhance dexamethasone-induced MAP kinase phosphatase-1 (MKP-1) expression in peripheral blood mononuclear cells. Experimental data suggest that vitamin D can potentially increase the therapeutic response to glucocorticoid and can be used as an add-on treatment in steroid-resistant asthmatics. Vitamin D stimulates the production and regulation of skin antimicrobial peptides, such as cathelicidins, which have both direct antimicrobial activity and induced host cellular response by triggering cytokine release. Recent evidence suggests that low blood vitamin D level is a risk factor for food allergy.

Vitamin D acts by binding to the vitamin D receptors (VDRs), which are located in a variety of tissues. VDRs have been identified on nearly all cells of the immune system including T cells, B cells, neutrophils, macrophages, and dendritic cells (DCs).

Vitamin D deficiency predisposes to gastrointestinal infections by changing gut micro-biota, which may promote the development of food allergy. However the detail mechanism how vitamin D affects or protects the development of allergic diseases is still unknown. Vitamin D level is determined by sun exposure.

Due to the fact that Lithuania, Latvia and Taiwan are located in different latitudes of north hemisphere with markedly different sun exposure, in this Joint collaboration study between Taiwan, Lithuanian and Latvia, we are going to study, (1). Serum vitamin D level in children and adults with AD and/or asthma in Lithuania, Latvia and Taiwan. (2). VDRs genetic polymorphisms of AD and/or asthma in children and adults in Lithuania, Latvia and Taiwan. (3). Finally, we would like to explore the gut microbiome of patients with AD and/or asthma in Lithuanian, Latvian and Taiwanese children and adults; and to estimate possible relationship between gut microbiome and vitamin D level and VDRs genetic polymorphisms. We believe that this study will be the first which compares the populations with different geographical and ecological factors having the same allergic diseases. We hope that these results will provide the answer about the role of vitamin D in the prevention, or in the future, in treatment of allergic diseases.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with mild to moderate asthma
  • Patients with mild to moderate atopic dermatitis
  • Healthy individuals

排除标准

  • Acute or chronic infections
  • Oncological diseases
  • Acute systemic autoimmune diseases
  • Use of systemic immunosuppressants (wait 1 month)
  • Use of vitamin D supplementation
  • Use of systemic antihistamines (wait 1 week)

结局指标

主要结局

Vitamin D level in serum in patients with atopic dermatitis, asthma and healthy individuals from Lithuania, Latvia and Taiwan

时间窗: 2nd year of study

Comparison of serum vitamin D level (25(OH)D) by ELISA between studied groups

Composition of gut microbiome in patients with atopic dermatitis, asthma and healthy individuals from Lithuania, Latvia and Taiwan

时间窗: 3rd year of study

Investigation and comparison of gut microbiome using genetic evaluation between studied groups

Vitamin D receptors (VDRs) genetic polymorphisms in patients with atopic dermatitis, asthma and healthy individuals from Lithuania, Latvia and Taiwan

时间窗: 2nd year of study

Comparison of VDRs genetic polymorphisms using genetic evaluation between studied groups

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brigita Sitkauskiene

Prof., Head of Department of Immunology and Allergology

Lithuanian University of Health Sciences

研究点 (1)

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