Retinal Changes in Vitamin D Deficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-12

Study Completion Date

2021-03-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pediatric Disorder Vitamin D Deficiency Retinal Disease Choroidal Disease Optic Nerve Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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Pediatric endocrinologist

Patient selection by pediatric endocrinologist on the basis of vitamin D

Group Type ACTIVE_COMPARATOR

Vitamin D deficiency

Intervention Type DIETARY_SUPPLEMENT

Ocular significance of vitamin D deficiency in pediatric cases

Ophthalmologist

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D deficiency

Ocular significance of vitamin D deficiency in pediatric cases

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes