Clinical trial NCT04891211: Retinal Changes in Vitamin D Deficiency
Official title: Evaluation of Retinal Structure in Pediatric Subjects With Vitamin D Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Disorder
Vitamin D Deficiency
Retinal Disease
Choroidal Disease
Optic Nerve Diseases
Lead sponsor: Adiyaman University
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 150
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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 weeks
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: choroidal thickness
timeFrame: up to 3 months
measure: retinal nerve fiber layer
timeFrame: up to 3 months
measure: The central retinal artery and vein calibers
timeFrame: up to 3 months
Secondary outcomes:
measure: blood vitamin D levels
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adıyaman U
state: None Selected
Study officials:
affiliation: Adiyaman University
name: Emre Aydemir, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.