Clinical trial NCT05598957: Evaluation of the Relationship of Vitamin D and Vitamin D Binding Protein with Disease Severity in Pediatric Sars-CoV2
Official title: Evaluation of the Relationship of Vitamin D and Vitamin D Binding Protein with Disease Severity in Pediatric Sars-CoV2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS CoV-2 Infection
Keywords: Sars Cov-2
Vitamin D Binding protein
free vitamin D
bioavailable vitamin D
children
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 82
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The relationship between free vitamin D levels and SARS CoV-2 infection severity.
timeFrame: baseline (at the time of diagnosis)
measure: The relationship between bioavailable vitamin D levels and SARS CoV-2 infection severity.
timeFrame: baseline (at the time of diagnosis)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki Training and Research Hospital
Study officials:
affiliation: Haseki Education and Research Hospital
name: mahmut caner US, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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.