VDD: Retinal Changes in Vitamin D Deficiency

• Sponsor: Adiyaman University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04891211
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Actual Duration (Days): 26
• Patients Per Site Per Month: 175.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Disorder; Vitamin D Deficiency; Retinal Disease; Choroidal Disease; Optic Nerve Diseases	Dietary Supplement: Vitamin D deficiency	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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 weeksGroup 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: Double (Investigator, Outcomes 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.
• Primary Purpose: Prevention
• Official Title: Evaluation of Retinal Structure in Pediatric Subjects With Vitamin D Deficiency
• Actual Study Start Date: Feb 12, 2021
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Mar 10, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. choroidal thickness [up to 3 months]

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

2. retinal nerve fiber layer [up to 3 months]

   Retinal nerve fiber layer will be detected by optical coherence tomography

3. The central retinal artery and vein calibers [up to 3 months]

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

Secondary Outcome Measures

1. blood vitamin D levels [up to 3 months]

   vitamin D deficiency or normal effects of vitamin D deficiency

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adıyaman U	Adıyaman	None Selected	Turkey

Sponsors and Collaborators

• Adiyaman University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emre Aydemir, Principal Investigator, Adiyaman University
• ClinicalTrials.gov Identifier: NCT04891211
• Other Study ID Numbers: EA180919
• First Posted: May 18, 2021
• Last Update Posted: May 18, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nervous System Diseases; Optic Nerve Diseases; Retinal Diseases; Choroid Diseases; Vitamin D Deficiency; Vitamin D

Study Results

No Results Posted as of May 18, 2021