Retinal Changes in Vitamin D Deficiency

Vitamin D Deficiency Clinical Trial

— VDD  

Official title:

Evaluation of Retinal Structure in Pediatric Subjects With Vitamin D Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04891211
• Other study ID #: EA180919
• Status: Completed
• Phase: N/A
• Start date: February 12, 2021
• Est. completion date: March 10, 2021

Study information

• Verified date: May 2021
• Source: Adiyaman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 10, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Choroidal Disease
• Nervous System Diseases
• Optic Nerve Diseases
• Pediatric Disorder
• Retinal Disease
• Retinal Diseases
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D deficiency
Ocular significance of vitamin D deficiency in pediatric cases

Locations

Country	Name	City	State
Turkey	Adiyaman U	Adiyaman	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Adiyaman University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	choroidal thickness	subfoveal, and subfoveal 1500-µm- and 3000-µm-diameter distance nasal and temporal areas	up to 3 months
Primary	retinal nerve fiber layer	Retinal nerve fiber layer will be detected by optical coherence tomography	up to 3 months
Primary	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	blood vitamin D levels	vitamin D deficiency or normal effects of vitamin D deficiency	up to 3 months