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Retinal Changes in Vitamin D Deficiency (VDD)

Primary Purpose

Pediatric Disorder, Vitamin D Deficiency, Retinal Disease

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Vitamin D deficiency

About this trial

This is an interventional prevention trial for Pediatric Disorder

Eligibility Criteria

8 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Adıyaman U

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Pediatric endocrinologist

Ophthalmologist

Arm Description

Patient selection by pediatric endocrinologist on the basis of vitamin D

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

Outcomes

Primary Outcome Measures

choroidal thickness

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

retinal nerve fiber layer

Retinal nerve fiber layer will be detected by optical coherence tomography

The central retinal artery and vein calibers

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

Secondary Outcome Measures

blood vitamin D levels

vitamin D deficiency or normal effects of vitamin D deficiency

Full Information

NCT ID

NCT04891211

First Posted

May 11, 2021

Last Updated

May 13, 2021

Sponsor

Adiyaman University

1. Study Identification

Unique Protocol Identification Number

NCT04891211

Brief Title

Retinal Changes in Vitamin D Deficiency

Acronym

VDD

Official Title

Evaluation of Retinal Structure in Pediatric Subjects With Vitamin D Deficiency

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

February 12, 2021 (Actual)

Primary Completion Date

March 1, 2021 (Actual)

Study Completion Date

March 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Adiyaman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

InvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pediatric endocrinologist

Arm Type

Active Comparator

Arm Description

Patient selection by pediatric endocrinologist on the basis of vitamin D

Arm Title

Ophthalmologist

Arm Type

No Intervention

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D deficiency

Intervention Description

Ocular significance of vitamin D deficiency in pediatric cases

Primary Outcome Measure Information:

Title

choroidal thickness

Description

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

Time Frame

up to 3 months

Title

retinal nerve fiber layer

Description

Retinal nerve fiber layer will be detected by optical coherence tomography

Time Frame

up to 3 months

Title

The central retinal artery and vein calibers

Description

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

Time Frame

up to 3 months

Secondary Outcome Measure Information:

Title

blood vitamin D levels

Description

vitamin D deficiency or normal effects of vitamin D deficiency

Time Frame

up to 3 months

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Pediatrics population

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emre Aydemir, M.D.

Organizational Affiliation

Adiyaman University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Adıyaman U

City

Adıyaman

State/Province

None Selected

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

23936865

Citation

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.

Results Reference

result

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Retinal Changes in Vitamin D Deficiency

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