Allergic ConjunctivitisNCT05839938
The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis
A study testing Vitamin D in people with Allergic Conjunctivitis, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Aug 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1. Children aged 6-18 years with allergic conjunctivitis (AC) diagnosed by ophthalmologists or allergists
Who cannot join
- Previous eye surgery
- Active eye infection
- Any active inflammatory eye disease except AC
- Systemic steroid use within 28 days of study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Vitamin D, Placebo
- 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
- Medical subject headings
- Conjunctivitis, Allergic, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DOther
Vitamin D (2000IU/day) for 6 months
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Vitamin D (2000IU/day) for 6 months Receives: Other: Vitamin D |
| Control group | Placebo comparator | placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of vitamin D
Vitamin D will be measured in a blood sample by ELISA to determine baseline status.
Measured: Month 0
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.
Measured: 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.
Measured: Month 0
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.
Measured: Month 0
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.
Measured: 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.
Measured: Month 0
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.
Measured: Month 6
Allergen-specific IgE
Plasma allergen-specific IgE will be measured by BioIC ®.
Measured: Month 0
Secondary outcomes (1)
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.)
Measured: Month 0 to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start8 Aug 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConjunctivitisStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839938
- Sponsor's protocol ID
- CMUH111-REC1-044
- Status last verified
- Jun 2024
- First submitted
- 21 Apr 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT05839938
- Acronym / sponsor ID
- CMUH111-REC1-044
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Vitamin DVitamin D (2000IU/day) for 6 months |
| Control group | Placebo comparator | Other: Placeboplacebo |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1. Children aged 6-18 years with allergic conjunctivitis (AC) diagnosed by ophthalmologists or allergists
Key exclusion criteria (4 listed)
- Previous eye surgery
- Active eye infection
- Any active inflammatory eye disease except AC
- Systemic steroid use within 28 days of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DVitamin D (2000IU/day) for 6 months | Other | Treatment group |
| PlaceboPlacebo | Other | Control group |
Primary outcome
Levels of vitamin D
Time frame: Month 0
Vitamin D will be measured in a blood sample by ELISA to determine baseline status.
Levels of vitamin D
Time frame: Month 6
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
Time frame: Month 0
Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.
Microbiome
Time frame: Month 0
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
Time frame: 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.
Total IgE
Time frame: Month 0
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
Time frame: 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.
Allergen-specific IgE
Time frame: Month 0
Plasma allergen-specific IgE will be measured by BioIC ®.
1 secondary outcome
mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ)
Time frame: Month 0 to Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Allergic Conjunctivitis, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of vitamin D (time frame: Month 0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.