Choroidal Disease, Optic Nerve Diseases, Pediatric Disorder, Retinal Disease, Vitamin D Deficiency
Conditions
Brief summary
Retinal tissue parameters of pediatric patients with vitamin D deficiency will be evaluated in this prospective case-control study. The patients will be divided into 2 groups according to the vitamin D level. Retinal vessel diameters, retinal nerve fiber evaluation, choroidal thickness will be evaluated. Choroidal thinning decrease in retinal artery diameter and increase in retinal vein diameter will be detected in the vitamin D deficiency group.
Detailed description
The study of the relationship between vitamin D status and retinal diseases is a new concept, and there is a large gap in research focusing on the pediatric population in the literature. The importance of vitamin D in retinal maturation and its role in the development of retinal diseases at a young age is being investigated. In this sense, as far as known, it is the first study investigating retinal structure parameters in pediatric patients with vitamin D deficiency.
Interventions
DIETARY_SUPPLEMENTVitamin D deficiency
Ocular significance of vitamin D deficiency in pediatric cases
Sponsors
Adiyaman University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Patients will be examined without knowing their vitamin D level. The OCT evaluations will be performed by a highly trained ophthalmic technician, and the compatibility of the results will be confirmed by two experienced retinal specialists.
Intervention model description
Group 1: 1) age \<18 years old; 2) serum vitamin D \[(25(OH) D), calcitriol\] level \<20 ngr/mL in previous two weeks Group 2: 1) age \<18 years old; 2) serum vitamin D \[(25(OH) D), calcitriol\] level \>20 ngr/mL in previous two weeks
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
(Group 1): 1. age \<18 years old 2. serum vitamin D \[(25(OH) D), calcitriol\] level \<20 ngr/mL in previous two weeks 3. visual acuity \>20/20 4. manifest refraction spherical equivalent \<3D 5. normal biomicroscopic and fundus examination.
Exclusion criteria
1. history of any chronic ocular diseases, except for refractive error (e.g., uveitis, glaucoma, retinopathy of prematurity) 2. history of ocular surgery (e.g., cataract, strabismus, open globe injury, laser photocoagulation) 3. having an ocular abnormality (e.g., persistent fetal vasculature, optic disc hypoplasia, fovea plana) 4. history of systemic diseases that have the potential to affect ocular tissues (e.g., diabetes mellitus, Graves' disease, albinism, Down syndrome, Fabry diseases, Wilson syndrome) 5. history of any systemic diseases that can affect the serum vitamin D level (e.g., parathormone or calcium metabolism disorders) 6. already receiving vitamin D treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| choroidal thickness | up to 3 months | subfoveal, and subfoveal 1500-µm- and 3000-µm-diameter distance nasal and temporal areas |
| retinal nerve fiber layer | up to 3 months | Retinal nerve fiber layer will be detected by optical coherence tomography |
| The central retinal artery and vein calibers | up to 3 months | The central retinal artery and vein calibers will be analyzed with the Interactive Vessel Analyzer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood vitamin D levels | up to 3 months | vitamin D deficiency or normal effects of vitamin D deficiency |
Countries
Turkey (Türkiye)
Outcome results
None listed