跳至主要内容
临床试验/NCT05839938
NCT05839938Enrolling By Invitation不适用

The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
150
试验地点
2
主要终点
Levels of vitamin D

研究概览

简要总结

A double-blind study to evaluate the role of vitamin D in corneal epithelial barrier function, ocular microbiome, ocular inflammation, and visual acuity of children with allergic conjunctivitis.

详细描述

The prevalence of allergic conjunctivitis (AC) has rapidly increased in recent decades, resulting in a significant global public health concern. The ocular surface is a unique mucosal immune compartment in which immunological features act in concert to foster a tolerant microenvironment (immune privilege). The corneal epithelial barrier is the first line of defense that forms a protective barrier against pathogens, pollutants, and allergens. The ocular microbiota has a role in maintaining the homeostasis of the ocular surface and preservation of barrier function. Vitamin D functions as enforcing intercellular junctions and maintaining intestinal epithelial barrier integrity; metabolites from the gut microbiota may also regulate expression of vitamin D receptor (VDR). Low serum vitamin D levels have been shown to predispose to a variety of allergic disorders. A recent study shows that corneas contain vitamin D and VDR; vitamin D enhances corneal epithelial barrier function. However, research data of the role of vitamin D in ocular microenvironment of AC are insufficient and controversial. In recent research, the investigators found allergic inflammation of ocular surface weakened corneal epithelial barrier, modulated the signal pathway of retinal pigment epithelial cells, and enhanced scleral tissue remodeling, resulting in myopia in progression. However, there are few studies available to investigate the role of vitamin D in ocular surface microenvironment, ocular inflammation, and visual acuity in AC. Moreover, understanding the interaction of vitamin D, ocular microbiota, and ocular inflammation may provide a new target for the development of therapeutic interventions of ocular allergy and restore visual function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children aged 6-18 years with allergic conjunctivitis (AC) diagnosed by ophthalmologists or allergists

排除标准

  • Previous eye surgery
  • Active eye infection
  • Any active inflammatory eye disease except AC
  • Systemic steroid use within 28 days of study

结局指标

主要结局

Levels of vitamin D

时间窗: Month 6

Vitamin D will be measured in a blood sample to follow the change from baseline in vitamin D level at month 6.

Microbiome

时间窗: Month 6

Nasal, subconjunctival and anal swabs will be used to detect ocular surface, nasal and intestinal microbiome by using 16S rRNA sequencing, and to follow the change from baseline in microbiome at month 6.

Allergen-specific IgE

时间窗: Month 0

Plasma allergen-specific IgE will be measured by BioIC ®.

Total IgE

时间窗: Month 6

Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to follow the change from baseline in total IgE at month 6.

Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein

时间窗: Month 0

Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.

次要结局

  • mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ)(Month 0 to Month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验