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

Sponsor
Marmara University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05598957
Collaborator
(none)
82
1
6
13.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Vitamin D Binding protein

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 Design

Study Type:
Observational
Actual Enrollment :
82 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of the Relationship of Vitamin D and Vitamin D Binding Protein With Disease Severity in Pediatric Sars-CoV2
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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)

Diagnostic Test: 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

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)

Diagnostic Test: 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

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)

Diagnostic Test: 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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haseki Training and Research Hospital Istanbul Turkey

Sponsors and Collaborators

  • Marmara University

Investigators

  • Principal Investigator: mahmut caner US, M.D, Haseki Education and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
mahmut caner us, Principal Investigator, Marmara University
ClinicalTrials.gov Identifier:
NCT05598957
Other Study ID Numbers:
  • 2022/10/17
First Posted:
Oct 31, 2022
Last Update Posted:
Nov 4, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by mahmut caner us, Principal Investigator, Marmara University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 4, 2022