Retinal Changes in Vitamin D Deficiency

Not Applicable

Completed

• Conditions: Retinal Disease; Optic Nerve Diseases; Pediatric Disorder; Vitamin D Deficiency; Choroidal Disease
• Interventions: Dietary Supplement: Vitamin D deficiency

• Registration Number: NCT04891211
• Lead Sponsor: Adiyaman University

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.

Study Timeline

• Study Start: 2021-02-12
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-10
• Status Verified: 2021-05
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-13
• Last Update Submitted: 2021-05-13
• Study First Posted: 2021-05-18
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pediatric endocrinologist	Vitamin D deficiency	Patient selection by pediatric endocrinologist on the basis of vitamin D

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
blood vitamin D levels	up to 3 months	vitamin D deficiency or normal effects of vitamin D deficiency

Trial Locations

Locations (1)

Adıyaman U; 🇹🇷 Adıyaman, None Selected, Turkey