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

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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Key information

Conditions

SARS CoV-2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D Binding protein

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

Primary outcomes

The relationship between free vitamin D levels and SARS CoV-2 infection severity.

Time frame: baseline (at the time of diagnosis)

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.
The relationship between bioavailable vitamin D levels and SARS CoV-2 infection severity.

Time frame: baseline (at the time of diagnosis)

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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Oct 31, 2022
Registry last updated: Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed