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临床试验/NCT04370808
NCT04370808已完成不适用

VITACOV: Vitamin D-related Polymorphisms and Vitamin D Levels as Risk Biomarkers of COVID-19 Infection Severity

University of Lisbon3 个研究点 分布在 1 个国家目标入组 517 人开始时间: 2020年8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
517
试验地点
3
主要终点
Differences in vitamin D blood levels between COVID-19 patients with different degrees of disease severity.

研究概览

简要总结

Vitamin D deficiency has been linked to hypertension, autoimmune, infectious and cardiovascular diseases which are risk factors for COVID-19. Moreover, COVID-19 patients have a very high prevalence of hypovitaminosis D (Turin data). Taken together, we aim to investigate whether genetic variants in vitamin D-related genes contribute to a poor COVID-19 outcome, particularly in hypertension and CV patients, proposing thus a personalized therapeutics based on vitamin D supplementation in order to reduce the severity and deaths.

详细描述

Collected data from Turin University indicate that hospitalized patients have a very high prevalence of hypovitaminosis D. Reports from China and Italy show that hypertension presents an increased risk of COVID-19-related death. Otherwise, observational studies suggest that 25(OH)D induces protection against respiratory pathogens while large-scale studies indicate that serum 25(OH)D-level is inversely correlated to hypertension prevalence. Recent published data (2020) shows that 66% of Portuguese adults present Vitamin D deficiency. HeartGenetics' genetic database with more than 8.500 Portuguese genotypes shows that the prevalence of vitamin D polymorphisms in this population is 4-fold higher than the EU average, increasing the risk of hypovitaminosis D.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults of 18 years and above.
  • COVID-19 patients admitted with mild to severe disease (admission to isolation room) or critical patients (admission to ICU).
  • Available to comply with study protocol and sign informed consent.

排除标准

  • Patients diagnosed with COVID-19 not admitted to hospital.
  • Patients unable to provide informed consent.

结局指标

主要结局

Differences in vitamin D blood levels between COVID-19 patients with different degrees of disease severity.

时间窗: Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection).

Differences in genetic variants in vitamin D-related genes between COVID-19 patients with different degrees of disease severity.

时间窗: Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection).

次要结局

  • Differences in vitamin D blood levels between COVID-19 patients in relation to duration of mechanical ventilation.(Through study completion, an average of 3 months.)
  • Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to length of stay in hospitals.(Through study completion, an average of 1 year.)
  • Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to duration of mechanical ventilation.(Through study completion, an average of 3 months.)
  • Differences in vitamin D blood levels between COVID-19 patients in relation to mortality.(Through study completion, an average of 3 months.)
  • Differences in vitamin D blood levels between COVID-19 patients in relation to length of stay in hospitals.(Through study completion, an average of 3 months.)
  • Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to mortality.(Through study completion, an average of 3 months.)

研究者

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

Fausto J. Pinto

Professor

University of Lisbon

研究点 (3)

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