Retinal Changes in Vitamin D Deficiency (VDD)

Adiyaman University

Status: Completed

Conditions: Optic Nerve Diseases; Pediatric Disorder; Vitamin D Deficiency; Retinal Disease; Choroidal Disease

Treatments: Dietary Supplement: Vitamin D deficiency

Study type: Interventional

Funder types: Other

Identifiers

NCT04891211

EA180919

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Pediatric endocrinologist

Active Comparator group

Description:

Patient selection by pediatric endocrinologist on the basis of vitamin D

Treatment:

Dietary Supplement: Vitamin D deficiency

Ophthalmologist

No Intervention group

Description:

1. Evaluation of the results by 2 different retina specialists during the examination of patients 2. Interpretation of the results without knowing the vitamin D level of patients