Retrospective Observational Study on the Risk Developing Long-COVID Syndrome After Acute COVID-19 Disease and in Contracting SARS-CoV-2 Infection After COVID-19 Vaccination in Relation to Vitamin D3 Suppl in Outpatients of Endocr Dept
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Analyse the rates of SARS-CoV-2 infection occurrence after anti-COVID-19 vaccination in patients treated with and without cholecalciferol.
研究概览
简要总结
The aim of this observational retrospective study is to evaluate the effect of supplementation with cholecalciferol D3 in reducing the risk of:
- occurence of Long COVID syndrome after acute COVID-19 illness
- occurence of SARS-CoV-2 infection after anti-COVID-19 vaccination
详细描述
Anamnestic, laboratory and therapeutic data will be collected during outpatient visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(For aim I):
- •outpatient with first visit on Endocrinology Department performed from 01/01/2020 to 31/12/2022
- •previous SARS CoV-2 infection
- •clinical,anamnestic and therapeutic data 6 months post SARS CoV-2 infection
- •data on cholecalciferol supplementation
- •signature of informed consent
排除标准
- •(For aim I):
- •pregnant or breastfeeding women
- •patients suffering from primary and/or acquired immunodeficiency and/or severe impairment of general clinical conditions
- •patients treated with drugs that interfere with vitamin D metabolism
- •first vaccination anti Sars COVID performed before the acute infection
- •first vaccination performed within 6 months of the acute infection
- •patients unable to sign the informed consent
- •Inclusion Criteria (For aim 2)
- •-- age ≥18
- •outpatient with first visit on Endocrinology Department performed from 01/01/2020 to 31/12/2022
- •vaccination with BNT162b2 Biontec mRNA Pfizer/BioNtech
- •clinical, anamnestic and therapeutic data 6 months post SARS CoV-2 infection
- •data on cholecalciferol supplementation
- •signature of informed consent
- •Exclusion Criteria (For aim 2):
- •pregnant or breastfeeding women
- •patients suffering from primary and/or acquired immunodeficiency and/or severe impairment of general clinical conditions
- •patients treated with drugs that interfere with vitamin D metabolism
- •additional vaccination performed before 6-12 months
- •acute infection before the vaccination
- •patients unable to sign the informed consent
研究组 & 干预措施
patients not on cholecalciferol therapy
patients on therapy with cholecalciferol
结局指标
主要结局
Analyse the rates of SARS-CoV-2 infection occurrence after anti-COVID-19 vaccination in patients treated with and without cholecalciferol.
时间窗: to 01/01/2020 from 31/12/2022
Analyse the rates of SARS-CoV-2 infection occurrence after anti-COVID-19 vaccination in oupatients treated with and without cholecalciferol between 01/01/2020 and 31/12/2022
Analyse the rates of Long COVID syndrome occurance after acute COVID-19 disease in patients treated with and without cholecalciferol.
时间窗: to 01/01/2020 from 31/12/2022
Analyse the rates of Long COVID syndrome occurance after acute COVID-19 disease in outpatients treated with and without cholecalciferol between 01/01/2020 and 31/12/2022
次要结局
未报告次要终点