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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-02-01

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.

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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.

Conditions

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SARS CoV-2 Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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uninfected Sars-CoV-2 group (Group 1)

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)

Vitamin D Binding protein

Intervention Type DIAGNOSTIC_TEST

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

mild Sars-CoV-2 group (Group 2)

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)

Vitamin D Binding protein

Intervention Type DIAGNOSTIC_TEST

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

moderate to severe Sars-CoV-2 group (Group 3)

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)

Vitamin D Binding protein

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Vitamin D Binding protein

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

Intervention Type DIAGNOSTIC_TEST

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.