Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04519034
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2020-08-03
Brief Title:
Vitamin D Status and Immune-inflammatory Status in Different UK Populations With COVID-19 Infection
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Retrospective Pilot Study of Vitamin D Status and Immune-inflammatory Status in Different UK Populations With COVID-19 Infection
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypothesis Serum Vitamin D 25OHD is significantly lower in severe versus non-severe COVID-19 infections and that this is a function of ethnicity There is an association between vitamin D status and various cytokines pro-inflammatory molecules
The primary objective of this research is to provide a snap shot of vitamin D status in patients from the South-East London area by age sex ethnicity and BMI and demonstrate ethnic differences in vitamin D status as well as its associations with severe vs non-severe COVID-19 infections
The secondary objective is to determine if there is an association between vitamin D status and various cytokines pro-inflammatory molecules and severity of disease
The primary objective of this research is to provide a snap shot of vitamin D status in patients from the South-East London area by age sex ethnicity and BMI and demonstrate ethnic differences in vitamin D status as well as its associations with severe vs non-severe COVID-19 infections
The secondary objective is to determine if there is an association between vitamin D status and various cytokines pro-inflammatory molecules and severity of disease
Detailed Description:
Worldwide there has been over 6 million cases and 380810 deaths from Coronavirus 2019 COVID-19 ECDC June 2020 According to the European Centre for Disease Prevention and Control ECDC risk factors for critical illness include elderly people above 70 years of age and people with underlying conditions such as hypertension diabetes cardiovascular disease chronic respiratory disease immune compromised status and obesity 734 of critically ill patients with BMI 30-40 In addition in the UK 32 of critically ill COVID-19 patients are of Black or Asian ethnic-minority background ICNARC April 10th 2020 There is therefore an urgent need to fully understand the risk factors for severe COVID-19 infection and find an effective treatment In COVID-19 infection those patients that required intensive care treatment have high circulating cytokines and chemokines TNF-α IL-2 IL-6 IL-7 IL-9 IL-17 IFN-γ MCP-1 and MIP-1α Severe COVID-19 infection appears therefore to be associated with a damaging hyperinflammation state In addition to a dysregulated cytokine response there is also dysregulation of immune cell populations in COVID-19 infection For example there is low T regs NK cell and CD8 and CD4 T cells in severe COVID-19 infection Moreover CD8 T cells appear to be an independent predictor for COVID-19 severity and treatment efficacy
Other than genetic factors eg HLA which may predispose to severe COVID-19 vitamin D 25OHD may be important for several reasons Firstly because 25OHD inadequacy is prevalent in European and US older adults 60 years Black and Asian minority ethnic population groups and in those with a high BMI Secondly because 25OHD is known to have important immunoregulatory roles eg in downregulating pro-inflammatory cytokines TNF-α IL-1 IL-2 IL-6 IL-8 IL-17 IFN-γ and upregulating anti-inflammatory TGFβ and IL-10 25OHD also promotes Treg and effector CD8 T cell differentiation and expansion Furthermore 25OHD has a role in preventing and reducing human respiratory infections eg influenza and in experimental animals is positively associated with virus specific CD8 T cells Vitamin D may also be an important modulator of hyperinflammatory response in patients with Covid-19 infection through cytokine storm suppression
As part of the Governments response to Covid-19 Public Health England has re-issued existing advice on vitamin D httpswwwnhsukconditionsvitamins-and-mineralsvitamin-d This study will provide important information on vitamin D status as a possible risk factor in relation to COVID-19 infection in UK elderly and ethnic minority populations Furthermore the data generated could also have important implications for future supplementation and or vaccination strategies for COVID-19
Other than genetic factors eg HLA which may predispose to severe COVID-19 vitamin D 25OHD may be important for several reasons Firstly because 25OHD inadequacy is prevalent in European and US older adults 60 years Black and Asian minority ethnic population groups and in those with a high BMI Secondly because 25OHD is known to have important immunoregulatory roles eg in downregulating pro-inflammatory cytokines TNF-α IL-1 IL-2 IL-6 IL-8 IL-17 IFN-γ and upregulating anti-inflammatory TGFβ and IL-10 25OHD also promotes Treg and effector CD8 T cell differentiation and expansion Furthermore 25OHD has a role in preventing and reducing human respiratory infections eg influenza and in experimental animals is positively associated with virus specific CD8 T cells Vitamin D may also be an important modulator of hyperinflammatory response in patients with Covid-19 infection through cytokine storm suppression
As part of the Governments response to Covid-19 Public Health England has re-issued existing advice on vitamin D httpswwwnhsukconditionsvitamins-and-mineralsvitamin-d This study will provide important information on vitamin D status as a possible risk factor in relation to COVID-19 infection in UK elderly and ethnic minority populations Furthermore the data generated could also have important implications for future supplementation and or vaccination strategies for COVID-19
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None