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

SARS CoV-2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05598957
• Other study ID #: 2022/10/17
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS CoV-2 Infection

Intervention

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 (ELISA kit) levels

Locations

Country	Name	City	State
Turkey	Haseki Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Charoenngam N, Shirvani A, Reddy N, Vodopivec DM, Apovian CM, Holick MF. Authors' Reply: Vitamin D Sufficiency and COVID-19: Is Vitamin D Binding Protein (and Its Polymorphism) the Missing Link? Endocr Pract. 2021 Jun;27(6):646-647. doi: 10.1016/j.eprac.2021.03.016. Epub 2021 Apr 2. No abstract available. — View Citation

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. — View Citation

Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):106 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)