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

M

Marmara University

Status

Completed

Conditions

SARS CoV-2 Infection

Treatments

Diagnostic Test: Vitamin D Binding protein

Study type

Observational

Funder types

Other

Identifiers

NCT05598957
2022/10/17

Details and patient eligibility

About

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.

Full description

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.

Enrollment

82 patients

Sex

All

Ages

1 to 18 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

82 participants in 3 patient groups

uninfected Sars-CoV-2 group (Group 1)
Description:
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)
Treatment:
Diagnostic Test: Vitamin D Binding protein
mild Sars-CoV-2 group (Group 2)
Description:
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)
Treatment:
Diagnostic Test: Vitamin D Binding protein
moderate to severe Sars-CoV-2 group (Group 3)
Description:
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)
Treatment:
Diagnostic Test: Vitamin D Binding protein

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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