The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 8, 2022
CompletedFirst Submitted
Initial submission to the registry
April 21, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedJuly 3, 2024
June 1, 2024
3 years
April 21, 2023
June 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Levels of vitamin D
Vitamin D will be measured in a blood sample by ELISA to determine baseline status.
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.
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.
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.
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.
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.
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.
Month 6
Allergen-specific IgE
Plasma allergen-specific IgE will be measured by BioIC ®.
Month 0
Secondary Outcomes (1)
mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ)
Month 0 to Month 6
Study Arms (2)
Treatment group
EXPERIMENTALVitamin D (2000IU/day) for 6 months
Control group
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- \. Children aged 6-18 years with allergic conjunctivitis (AC) diagnosed by ophthalmologists or allergists
You may not qualify if:
- Previous eye surgery
- Active eye infection
- Any active inflammatory eye disease except AC
- Systemic steroid use within 28 days of study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, 404, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2023
First Posted
May 3, 2023
Study Start
August 8, 2022
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
July 3, 2024
Record last verified: 2024-06