Investigating the Role of Vitamin D in the Morbidity of COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 986
- 试验地点
- 1
- 主要终点
- COVID-19 infection
研究概览
简要总结
The 2019 novel coronavirus disease (COVID-2019) pandemic is an enormous health issue of worldwide scale. Prevention and/or treatment with a widely-available and already-licensed product such as vitamin D (cholecalciferol) could have a large impact on healthcare worldwide. Given ethnic variation in vitamin D production, this could help to address the discrepancies in how people of different ethnicities are affected by COVID-19. There are currently no published studies analysing either individual-level evidence on the effect of vitamin D status on COVID-19 outcomes, or any prospective studies planning on following-up patients with reference to vitamin D and COVID-19 infection.
The study will have 2 arms. Arm 1 will recruit patients hospitalised with COVID-19. Vitamin D levels will be measured in these patients and compared with outcome measures of COVID-19 severity. In Arm 2, patients will be recruited prospectively from local general practices (GPs) with measurement of vitamin D levels at enrolment. They will be followed up after 6 months to determine whether baseline vitamin D levels correspond with developing COVID-19. Data will be collected from a mixture of patient medical records, electronic patient records, laboratory data and from patients themselves. Data in Arm 1 will be analysed with a combination of linear and logistic regression, as appropriate, and with adjustment for covariates. Data in Arm 2 will be analysed as a case-control study, with adjustment for covariates.
The primary objectives are to determine whether vitamin D levels affect outcomes in COVID-19 infection and whether vitamin D deficiency is associated with increased risk.
详细描述
STUDY DESIGN Arm 1: Hospital in-patients with a clinical diagnosis of COVID-19 This will be an observational cohort study of patients hospitalised at Tameside General Hospital with a clinical diagnosis of COVID-19, as defined by the clinical coding department. Patient identifiers will be extracted by the coding department and held on a secure server at Tameside Hospital. Identifiers will be used to ensure serum samples already taken as part of routine clinical management of these patients can be processed for a vitamin D level. No additional blood samples will need to be taken.
Patient demographic details will be extracted from their clinical notes and electronic patient records, then placed on an anonymised database for analysis. Data will be analysed to determine the following:
- Are vitamin D levels associated with outcomes/prognosis in patients hospitalised with COVID-19?
- Are vitamin D levels associated with ethnicity in patients hospitalised with COVID-19?
- Are vitamin D levels associated with comorbidity in patients hospitalised with COVID-19?
Projected recruitment is 200 patients to be opportunistically recruited who are undergoing usual clinical care for COVID-19.
Arm 2: Primary care patients prospectively studied with reference to baseline vitamin D and risk of COVID-19 Patients will be prospectively recruited from local GP surgeries within the Tameside and Glossop Clinical Commissioning Group. Patients will be consented by Good Clinical Practice (GCP)-certified practitioners. A serum sample will be collected on recruitment for a baseline vitamin D level to be obtained. Patient contact details will be collected, as well as baseline health status and comorbidities, then stored on an encrypted database on a secure server at Tameside Hospital. Vitamin D levels will be communicated to GP surgeries and GPs can decide whether to treat patients according to local treatment guidelines for suboptimal vitamin D. After 6 months, patients will be followed-up via telephone interview, in order to ascertain whether they have developed COVID-19, any treatment outcomes for this, and whether they have been treated with vitamin D in the interim in primary/secondary/tertiary care.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •In-patient admitted to Tameside General Hospital.
- •Clinical diagnosis of COVID-19 - not necessary for SARS-CoV-2 swab to be positive.
- •Patients on vitamin D treatment to be included, but this will be adjusted for in analysis.
排除标准
- •Final clinical diagnosis NOT COVID-
- •ARM 2 - prospective primary care case-control study
- •Inclusion Criteria:
- •Patients on vitamin D treatment to be included, but this will be adjusted for in analysis.
- •Exclusion Criteria:
- •On active treatment for malignancy/diagnosis of cancer within 6 months prior to enrolment.
- •Patients on immunosuppression e.g. for autoimmune disease, for solid organ transplant.
结局指标
主要结局
COVID-19 infection
时间窗: 1 year
Development of COVID-19 during case-control study
Oxygen therapy for COVID-19
时间窗: 1 year
Whether hospitalised COVID-19 patients require oxygen therapy
Discharge following COVID-19 hospitalisation
时间窗: 1 year
Whether patients hospitalised with COVID-19 were discharged
Death due to COVID-19
时间窗: 1 year
Whether patients hospitalised with COVID-19 died in hospital
次要结局
未报告次要终点