Evaluation of the Relationship of Vitamin D and Vitamin D Binding Protein With Disease Severity in Pediatric Sars-CoV2

Study Overview
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Brief Summary
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There were many studies in the literature discussing the effects of vitamin D deficiency and the role of vitamin D supplementation in SARS-CoV-2 patients. Combined with the possible impact of vitamin D on the pathogenesis of SARS-CoV-2 infection, it is concluded that VDBP-regulated bioavailable and free vitamin D concentrations modulate the human immune system response to viral infections. Because of the gap in the literature, it was emphasized that studies should focus on vitamin D binding protein (VDBP) and gene polymorphism. In this study, it was aimed to investigate the relationship between SARS-CoV-2 infection severity and free and bioavailable vitamin D levels.

Detailed Description
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It was aimed to investigate the relationship between SARS-CoV-2 infection severity and free and bioavailable vitamin D levels. This study was planned as a case-control study with patients hospitalized in the Haseki Training and Research Hospital Pediatric Infection Service. A total of 82 children, including at least 20 patients in each group were included in the study. The study group was divided into three groups according to COVID-19 WHO clinical progression Scale: unaffected (Group 1), mild (Group 2) and moderate (group 3). In order to investigate the relationship between disease severity and free and bioavailable vitamin D; 25OH vitamin d (μg/L), albumin (g/l) and VDBP levels (ELISA) were used. Vitamin D metabolites were calculated by using Bikle and Vermeulen methods (free Vitamin D BIKLE, free vitamin DVERMEULEN, bioavailable vitamin D). And these three vitamin D parameter levels were compared between groups.

Official Title
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Evaluation of the Relationship of Vitamin D and Vitamin D Binding Protein With Disease Severity in Pediatric Sars-CoV2

Conditions
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SARS CoV-2 Infection

Intervention / Treatment
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* Diagnostic Test: Vitamin D Binding protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 1-18 years old, Positive for SARS-CoV-2 PCR or positive for IgM in the SARS-CoV-2 antibody test (card test or ELISA), Do not have a chronic disease (cystic fibrosis, etc.), Volunteer to participate in the study. Exclusion Criteria: Being < 1 year of age

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| uninfected Sars-CoV-2 group (Group 1)<br>The study group was divided into three groups according to COVID-19 WHO clinical progression Scale: no viral RNA detected, uninfected Sars-CoV-2 patients (Group 1) | Diagnostic Test: Vitamin D Binding protein<br>* Vitamin D-free and bioavailable metabolites were calculated by using Bikle and Vermeulen methods with using albumin, 25-OH vitamin D, vitamin D binding protein (ELİSA kit) levels<br>|
| mild Sars-CoV-2 group (Group 2)<br>The study group was divided into three groups according to COVID-19 WHO clinical progression Scale: viral RNA detected but asymptomatic disease, ambulatory mild disease (Group 2) | Diagnostic Test: Vitamin D Binding protein<br>* Vitamin D-free and bioavailable metabolites were calculated by using Bikle and Vermeulen methods with using albumin, 25-OH vitamin D, vitamin D binding protein (ELİSA kit) levels<br>|
| moderate to severe Sars-CoV-2 group (Group 3)<br>The study group was divided into three groups according to COVID-19 WHO clinical progression Scale: hospitalized moderate disease, moderate to severe Sars-CoV-2 patients (group 3) | Diagnostic Test: Vitamin D Binding protein<br>* Vitamin D-free and bioavailable metabolites were calculated by using Bikle and Vermeulen methods with using albumin, 25-OH vitamin D, vitamin D binding protein (ELİSA kit) levels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between free vitamin D levels and SARS CoV-2 infection severity. | The differences between free vitamin D levels in SARS CoV-2 infected patients according to the symptom severity. SARS CoV-2 infection severity will be categorized according to COVID19 WHO clinical progression Scale as uninfected, mild, moderate to severe. | baseline (at the time of diagnosis) | 
| The relationship between bioavailable vitamin D levels and SARS CoV-2 infection severity. | The differences between bioavailable vitamin D levels in SARS CoV-2 infected patients according to the symptom severity. SARS CoV-2 infection severity will be categorized according to COVID19 WHO clinical progression Scale as uninfected, mild, moderate to severe. | baseline (at the time of diagnosis) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sars Cov-2, Vitamin D Binding protein, free vitamin D, bioavailable vitamin D, children