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Completed

NCT Number: NCT04891211

Retinal Changes in Vitamin D Deficiency

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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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adıyaman U

Adıyaman, None Selected, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Group 1):

  • age <18 years old
  • serum vitamin D [(25(OH) D), calcitriol] level <20 ngr/mL in previous two weeks
  • visual acuity >20/20
  • manifest refraction spherical equivalent <3D
  • normal biomicroscopic and fundus examination.

Exclusion criteria

  • history of any chronic ocular diseases, except for refractive error (e.g., uveitis, glaucoma, retinopathy of prematurity)
  • history of ocular surgery (e.g., cataract, strabismus, open globe injury, laser photocoagulation)
  • having an ocular abnormality (e.g., persistent fetal vasculature, optic disc hypoplasia, fovea plana)
  • 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)
  • history of any systemic diseases that can affect the serum vitamin D level (e.g., parathormone or calcium metabolism disorders)
  • already receiving vitamin D treatment.

Treatment and study plan

Vitamin D deficiency

Dietary Supplement

Ocular significance of vitamin D deficiency in pediatric cases

Primary outcomes

  1. choroidal thickness

    Time frame: up to 3 months

    subfoveal, and subfoveal 1500-µm- and 3000-µm-diameter distance nasal and temporal areas

  2. retinal nerve fiber layer

    Time frame: up to 3 months

    Retinal nerve fiber layer will be detected by optical coherence tomography

  3. The central retinal artery and vein calibers

    Time frame: up to 3 months

    The central retinal artery and vein calibers will be analyzed with the Interactive Vessel Analyzer

Secondary outcomes

  1. blood vitamin D levels

    Time frame: up to 3 months

    vitamin D deficiency or normal effects of vitamin D deficiency

Sponsors and collaborators

Lead sponsor

Adiyaman University

Other

Registry information

Official study title

Evaluation of Retinal Structure in Pediatric Subjects With Vitamin D Deficiency

Acronym: VDD

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 18, 2021
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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