Vitamin D study and Covid-19 [COVID-19]
Research type
Research Study
Full title
Retrospective pilot study of vitamin D status and immune-inflammatory status in different UK populations with COVID-19 Infection.
IRAS ID
285176
Contact name
Agata Sobczynska-Malefora
Contact email
Sponsor organisation
R&D Department
Duration of Study in the UK
0 years, 2 months, 0 days
Research summary
Vitamin D plays an essential role in immune response, and status has previously been linked to susceptibility to respiratory disease. Vitamin D may also be an important modulator of hyperinflammatory response in patients with Covid-19 infection through cytokine storm suppression. Vitamin D inadequacy is prevalent in older adults, Black and Asian minority ethnic population groups and in those with a high BMI. In the UK, 32% of critically ill COVID-19 patients are of Black or Asian ethnic-minority background.\nThe proposed preliminary pilot study is to provide both the data to support our hypothesis (see below) and the supporting evidence for approvals for larger study design, and research grant applications. \n\nThe primary objective of this retrospective observational pilot research is to test the hypothesis that vitamin D (25(OH)D) is significantly lower in severe versus non-severe COVID-19 infections and that this is a function of ethnicity. The secondary objective is to determine if there is an association between vitamin D status and various cytokines (pro-inflammatory molecules).\n\nWe will:\n\n1.\tAudit 1: Acquire all vitamin D results performed by the Nutristasis Unit at St. Thomas’ since January 2020 (N= ~15000) together with age, weight and height if available, ethnicity and other relevant laboratory markers (Ca, adjusted calcium, PTH, Mg, phosphate, liver and renal profile, Covid-19 screening, CRP, Haematinics, FBC) if they were tested within two weeks of the sample being measured for vitamin D. The results of this audit will provide us with a snap shot of vitamin D status in patients from the South-East London area by age, sex, ethnicity and BMI. Correlation analysis will also be undertaken with other laboratory parameters.\n\n2.\tAudit 2: We will collect all Covid-19 screening results together with vitamin D, ethnicity, age, weight, height, length of stay in hospital including ICU (if applicable), type of illness, recovered or not, associated health conditions, CRP, Ferritin, Haematinics, vitamin A and E, procalcitonin, LDH, INR, fibrinogen, FBC, D-dimers, CK, Troponin-T, cytokines, renal function and electrolytes from patients tested at GSTT NHS Trust. These results will be obtained from EPR/Covid Analytics team.\nWe expect that only a small number of patients who had Covid-19 screening performed would have had vitamin D, cytokines and other markers measured. However, we estimate that we will be able to identify a sufficient number of Covid-19 patients for regression and correlation analysis from this data.\n\n3.\tIn addition, we would like to measure vitamin D concentration in surplus Covid-19 positive samples (N=~30-35) sent from GSTT patients for cytokines analysis (CY19: IL1b, IL6, IL8 and TNFa and/or CY20: IL2ra, IL10, IL17 and INFg) to Clinical Research and Development, Contract R&D Department, King’s College Hospital, Denmark Hill. These samples are being stored at -80C following cytokines assessment. We have already established the suitability of these samples for testing and the Clinical Research and Development Laboratory at Denmark Hill are happy to make these anonymised samples available for the proposed pilot study if the appropriate permission for analysis is granted. The data from audit 2 will be matched to these cases and regression and correlation analysis performed.\n\n\n
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
20/YH/0204
Date of REC Opinion
24 Jul 2020
REC opinion
Further Information Favourable Opinion