Retinal Changes in Vitamin D Deficiency

NCT04891211 | Completed

• 1 other identifier: EA180919
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• choroidal thickness

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

  up to 3 months

• retinal nerve fiber layer

  Retinal nerve fiber layer will be detected by optical coherence tomography

  up to 3 months

• The central retinal artery and vein calibers

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

  up to 3 months

Secondary Outcomes (1)

• blood vitamin D levels

  up to 3 months

Study Arms (2)

Pediatric endocrinologist

ACTIVE COMPARATOR

Patient selection by pediatric endocrinologist on the basis of vitamin D

Dietary Supplement: Vitamin D deficiency

Ophthalmologist

NO INTERVENTION

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

Interventions

Vitamin D deficiency DIETARY_SUPPLEMENT

Ocular significance of vitamin D deficiency in pediatric cases

Pediatric endocrinologist

Eligibility Criteria

• Age: 8 Years - 17 Years
• Gender Eligibility Details: Pediatrics population
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adiyaman University: lead

Study Sites (1)

Adıyaman U

Adıyaman, None Selected, Turkey (Türkiye)

Location

Related Publications (1)

• Poon M, Craig ME, Kaur H, Cusumano J, Sasongko MB, Wong TY, Donaghue KC. Vitamin D deficiency is not associated with changes in retinal geometric parameters in young people with type 1 diabetes. J Diabetes Res. 2013;2013:280691. doi: 10.1155/2013/280691. Epub 2013 Jul 7.

  PMID: 23936865 RESULT

MeSH Terms

Conditions

Vitamin D Deficiency; Retinal Diseases; Choroid Diseases; Optic Nerve Diseases

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Eye Diseases; Uveal Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Emre Aydemir, M.D.

  Adiyaman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 18, 2021
• Study Start: February 12, 2021
• Primary Completion: March 1, 2021
• Study Completion: March 10, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Participants will be examined at same times of the day in order not to affect the measurement results.
• Access Criteria: Participants will be divided into groups according to their vitamin D levels

Locations

TU (1)