An interventional study of Vitamin D and Placebo in Allergic Conjunctivitis, sponsored by China Medical University Hospital. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by China Medical University Hospital · Not applicable, Interventional, and Treatment
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.
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.
210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.
This study's planned enrollment of 150 is above the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.
Browse Conjunctivitis, Allergic studies →China Medical University Hospital is the lead sponsor of 479 studies on the registry; 115 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vitamin D (2000IU/day) for 6 months
Other: Vitamin D
placebo
Other: Placebo
Vitamin D (2000IU/day) for 6 months
Placebo
Levels of vitamin D
Vitamin D will be measured in a blood sample by ELISA to determine baseline status.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 6
Allergen-specific IgE
Plasma allergen-specific IgE will be measured by BioIC ®.
Time frame: Month 0
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.)
Time frame: Month 0 to Month 6
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