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

Completed

• Conditions: SARS CoV-2 Infection
• Interventions: Diagnostic Test: Vitamin D Binding protein

• Registration Number: NCT05598957
• Lead Sponsor: Marmara University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-31
• Primary Completion: 2022-12-01
• Study Completion: 2023-02-01
• Status Verified: 2023-03
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The relationship between bioavailable vitamin D levels and SARS CoV-2 infection severity.	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.
The relationship between free vitamin D levels and SARS CoV-2 infection severity.	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.

Trial Locations

Locations (1)

Haseki Training and Research Hospital; 🇹🇷 Istanbul, Turkey