Retinal Changes in Vitamin D Deficiency (VDD)

Evaluation of Retinal Structure in Pediatric Subjects With 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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Optic Nerve Diseases; Pediatric Disorder; Retinal Disease; Choroidal Disease
• Intervention / Treatment: Dietary supplement: Vitamin D deficiency

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • None Selected
    • Adıyaman, None Selected, Turkey
      • Adıyaman U

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pediatric endocrinologist; Patient selection by pediatric endocrinologist on the basis of vitamin D	Dietary supplement: Vitamin D deficiency; Ocular significance of vitamin D deficiency in pediatric cases
No Intervention: Ophthalmologist; Evaluation of the results by 2 different retina specialists during the examination of patients; Interpretation of the results without knowing the vitamin D level of patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood vitamin D levels	vitamin D deficiency or normal effects of vitamin D deficiency	up to 3 months

Collaborators and Investigators

• Sponsor: Adiyaman University
• Investigators: Principal Investigator: Emre Aydemir, M.D., Adiyaman University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 10, 2021

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Nutrition Disorders; Uveal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Cranial Nerve Diseases; Retinal Diseases; Vitamin D Deficiency; Nervous System Diseases; Optic Nerve Diseases; Choroid Diseases; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: EA180919

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Participants will be told what the plan provided and how it worked. Information will be given about when he will participate in the study and the measurements to be taken for the study.

It will be emphasized that there was nothing that harmed the participants in the examinations.

• IPD Sharing Time Frame: Participants will be examined at same times of the day in order not to affect the measurement results.
• IPD Sharing Access Criteria: Participants will be divided into groups according to their vitamin D levels
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No