Pediatric DisorderVDDNCT04891211
Retinal Changes in Vitamin D Deficiency
A study testing Vitamin D deficiency in people with Pediatric Disorder and Vitamin D Deficiency, run by Adiyaman University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Disorder, Vitamin D Deficiency, Retinal Disease
- What is being tested?
- Vitamin D deficiency
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2021to 10 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Disorder, Vitamin D Deficiency, Retinal Disease, Choroidal Disease, Optic Nerve Diseases
- Being tested
- Vitamin D deficiency
- Medical subject headings
- Vitamin D Deficiency, Retinal Diseases, Choroid Diseases, Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D deficiencyDietary supplement
Ocular significance of vitamin D deficiency in pediatric cases
| Study group | Role | What they receive |
|---|---|---|
| Pediatric endocrinologist | Active comparator | Patient selection by pediatric endocrinologist on the basis of vitamin D Receives: Dietary Supplement: Vitamin D deficiency |
| Ophthalmologist | No intervention | 1. Evaluation of the results by 2 different retina specialists during the examination of patients 2. Interpretation of the results without knowing the vitamin D level of patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
choroidal thickness
subfoveal, and subfoveal 1500-µm- and 3000-µm-diameter distance nasal and temporal areas
Measured: up to 3 months
retinal nerve fiber layer
Retinal nerve fiber layer will be detected by optical coherence tomography
Measured: 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
Measured: up to 3 months
Secondary outcomes (1)
blood vitamin D levels
vitamin D deficiency or normal effects of vitamin D deficiency
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start12 Feb 2021
- Primary completion1 Mar 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Aydemir, Adiyaman University
- Investigators
- Emre Aydemir, M.D., Principal investigator, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891211
- Sponsor's protocol ID
- EA180919
- Acronym
- VDD
- Status last verified
- May 2021
- First submitted
- 11 May 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 23936865
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Retinal Structure in Pediatric Subjects With Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT04891211
- Acronym / sponsor ID
- VDD / EA180919
- Conditions
- Pediatric Disorder, Vitamin D Deficiency, Retinal Disease, Choroidal Disease, Optic Nerve Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Pediatric endocrinologist | Active comparator | Dietary Supplement: Vitamin D deficiencyPatient selection by pediatric endocrinologist on the basis of vitamin D |
| Ophthalmologist | No intervention | –1. Evaluation of the results by 2 different retina specialists during the examination of patients 2. Interpretation of the results without knowing the vitamin D level of patients |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D deficiencyOcular significance of vitamin D deficiency in pediatric cases | Dietary supplement | Pediatric endocrinologist |
Primary outcome
choroidal thickness
Time frame: up to 3 months
subfoveal, and subfoveal 1500-µm- and 3000-µm-diameter distance nasal and temporal areas
retinal nerve fiber layer
Time frame: up to 3 months
Retinal nerve fiber layer will be detected by optical coherence tomography
The central retinal artery and vein calibers
Time frame: up to 3 months
The central retinal artery and vein calibers will be analyzed with the Interactive Vessel Analyzer
1 secondary outcome
blood vitamin D levels
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Results publication: PubMed 23936865Poon 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Pediatric Disorder
RecruitingPhase 3
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Pediatric Migraine
RecruitingObservational study
Validation of the D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Children Aged 8 to 18 Months
Pediatric Feeding Disorder, Feeding Difficulties in Infants and Young Children
Recruiting
Brain MRF in Children, Adolescents and Young Adults With Acute Leukemia
Acute Leukemia, Acute Lymphoblastic Leukemia, Pediatric
RecruitingPhase 3
Morphine or Ketamine for Analgesia
Abdominal Pain, Isolated Extremity Fracture
RecruitingObservational study
Newborn Screening and Early Diagnosis of AADC Deficiency in the Ligurian Population
Neurology, Aromatic Amino Acid Decarboxylase Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emre Aydemir, M.D. principal investigator
Adiyaman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D deficiency in people with Pediatric Disorder and Vitamin D Deficiency, run by Adiyaman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
choroidal thickness (time frame: up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04891211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021; AzTrials last refreshed its copy on 29 Oct 2026.