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临床试验/NCT05598957
NCT05598957已完成不适用

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

Marmara University1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1
主要终点
The relationship between bioavailable vitamin D levels and SARS CoV-2 infection severity.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Being < 1 year of age

结局指标

主要结局

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

时间窗: 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.

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

mahmut caner us

Principal Investigator

Marmara University

研究点 (1)

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