The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis
Primary Purpose
Allergic Conjunctivitis
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring allergic conjunctivitis, immune privilege, corneal epithelial barrier, microbiota, vitamin D, ocular microenvironment, visual acuity, vitamin D receptor gene polymorphism, ocular surface and intraocular inflammation
Eligibility Criteria
Inclusion Criteria: 1. Children aged 6-18 years with allergic conjunctivitis (AC) diagnosed by ophthalmologists or allergists Exclusion Criteria: Previous eye surgery Active eye infection Any active inflammatory eye disease except AC Systemic steroid use within 28 days of study
Sites / Locations
- China Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment group
Control group
Arm Description
Vitamin D (2000IU/day) for 6 months
placebo
Outcomes
Primary Outcome Measures
Levels of vitamin D
Vitamin D will be measured in a blood sample by ELISA to determine baseline status.
Levels of vitamin D
Vitamin D will be measured in a blood sample to follow the change from baseline in vitamin D level at month 6.
Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein
Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.
Microbiome
Nasal, subconjunctival and anal swabs will be used to detect ocular surface, nasal and intestinal microbiome by using 16S rRNA sequencing to determine baseline status.
Microbiome
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.
Total IgE
Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to determine baseline status.
Total IgE
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.
Allergen-specific IgE
Plasma allergen-specific IgE will be measured by BioIC ®.
Secondary Outcome Measures
mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ)
mini-RQLQ is to measure a the level of severity of a set of symptoms of functional impairments due to rhinoconjunctivitis. 14 questions each range 0-6 (6 is most severe). Total range 0-84 (higher scores reflect lower quality of life.)
Full Information
NCT ID
NCT05839938
First Posted
April 21, 2023
Last Updated
May 4, 2023
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05839938
Brief Title
The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis
Official Title
The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
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
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
allergic conjunctivitis, immune privilege, corneal epithelial barrier, microbiota, vitamin D, ocular microenvironment, visual acuity, vitamin D receptor gene polymorphism, ocular surface and intraocular inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Vitamin D (2000IU/day) for 6 months
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Other
Intervention Name(s)
Vitamin D
Intervention Description
Vitamin D (2000IU/day) for 6 months
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Levels of vitamin D
Description
Vitamin D will be measured in a blood sample by ELISA to determine baseline status.
Time Frame
Month 0
Title
Levels of vitamin D
Description
Vitamin D will be measured in a blood sample to follow the change from baseline in vitamin D level at month 6.
Time Frame
Month 6
Title
Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein
Description
Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.
Time Frame
Month 0
Title
Microbiome
Description
Nasal, subconjunctival and anal swabs will be used to detect ocular surface, nasal and intestinal microbiome by using 16S rRNA sequencing to determine baseline status.
Time Frame
Month 0
Title
Microbiome
Description
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.
Time Frame
Month 6
Title
Total IgE
Description
Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to determine baseline status.
Time Frame
Month 0
Title
Total IgE
Description
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.
Time Frame
Month 6
Title
Allergen-specific IgE
Description
Plasma allergen-specific IgE will be measured by BioIC ®.
Time Frame
Month 0
Secondary Outcome Measure Information:
Title
mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ)
Description
mini-RQLQ is to measure a the level of severity of a set of symptoms of functional impairments due to rhinoconjunctivitis. 14 questions each range 0-6 (6 is most severe). Total range 0-84 (higher scores reflect lower quality of life.)
Time Frame
Month 0 to Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Children aged 6-18 years with allergic conjunctivitis (AC) diagnosed by ophthalmologists or allergists
Exclusion Criteria:
Previous eye surgery
Active eye infection
Any active inflammatory eye disease except AC
Systemic steroid use within 28 days of study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang-Ching Wei
Phone
886422052121
Ext
14639
Email
d5522@mail.cmuh.org.tw
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang-Ching Wei
Phone
886422052121
Ext
14639
Email
d5522@mail.cmuh.org.tw
12. IPD Sharing Statement
Learn more about this trial
The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis
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