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

NCT05598957 | Completed

• 1 other identifier: 2022/10/17
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS CoV-2 Infection

Keywords

Sars Cov-2; Vitamin D Binding protein; free vitamin D; bioavailable vitamin D; children

Outcome Measures

Primary Outcomes (2)

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

  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.

  baseline (at the time of diagnosis)

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

  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.

  baseline (at the time of diagnosis)

Study Arms (3)

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

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

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

Interventions

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

mild Sars-CoV-2 group (Group 2); moderate to severe Sars-CoV-2 group (Group 3); uninfected Sars-CoV-2 group (Group 1)

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Sars-CoV-2 diagnosed children aged between 1-18 years old and whose parents sign the informed consent form to participate in the study.

You may qualify if:

• 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.

You may not qualify if:

• Being \< 1 year of age

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• Us MC, Devrim Lanpir A, Ozdatli Kurtulus S, Yagci M, Akarsu O, Sahin K, Akkoc G. The role of free vitamin D and vitamin D binding protein in SARS-Cov-2 infection in children. Pediatr Int. 2023 Jan-Dec;65(1):e15680. doi: 10.1111/ped.15680.

  PMID: 37888613 BACKGROUND

• May JM. Triacylglycerol turnover in large and small rat adipocytes: effects of lipolytic stimulation, glucose, and insulin. J Lipid Res. 1982 Mar;23(3):428-36.

  PMID: 7042881 BACKGROUND

• Alsina M, Martinez-Picado J, Jofre J, Blanch AR. A medium for presumptive identification of Vibrio anguillarum. Appl Environ Microbiol. 1994 May;60(5):1681-3. doi: 10.1128/aem.60.5.1681-1683.1994.

  PMID: 8017947 BACKGROUND

• Speeckaert MM, Delanghe JR. Vitamin D binding protein and its polymorphisms may explain the link between vitamin D deficiency and COVID-19. Sci Prog. 2021 Oct;104(4):368504211053510. doi: 10.1177/00368504211053510. No abstract available.

  PMID: 34723751 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

to investigate the free and bioavailable vitamin D, 25OH vitamin d (μg/L), albumin (g/l) and VDBP levels, a 5 ml blood sample was collected from patients

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• mahmut caner US, M.D

  Haseki Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 31, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: November 21, 2024

Record last verified: 2023-03

Locations

TU (1)