Vitamin D Status and Immune-inflammatory Status in Different UK Populations With COVID-19 Infection

July 27, 2021 updated by: Guy's and St Thomas' NHS Foundation Trust

Retrospective Pilot Study of Vitamin D Status and Immune-inflammatory Status in Different UK Populations With COVID-19 Infection

Hypothesis: Serum Vitamin D (25(OH)D) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Worldwide there has been over 6 million cases and 380,810 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 (73.4% 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, e.g. HLA, which may predispose to severe COVID-19, vitamin D (25(OH)D) may be important for several reasons. Firstly because 25(OH)D 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 25(OH)D is known to have important immunoregulatory roles e.g. 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. 25(OH)D also promotes Treg and effector CD8+ T cell differentiation and expansion. Furthermore, 25(OH)D has a role in preventing and reducing human respiratory infections e.g. 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 Government's response to Covid-19, Public Health England has re-issued existing advice on vitamin D: https://www.nhs.uk/conditions/vitamins-and-minerals/vitamin-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 Type

Observational

Enrollment (Actual)

27628

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 100 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients tested for vitamin D and Covid-19

Description

Inclusion Criteria:

  • All patients tested for vitamin D and Covid-19

Exclusion Criteria:

  • not applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Audit 1
All vitamin D results performed 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)
Other: no intervention
There will be no intervention
Audit 2
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.
Other: no intervention
There will be no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collecting vitamin D results in patients from the South-East London area together with age, sex, ethnicity and BMI and other relevant laboratory results.
Time Frame: January-June 2020
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 will be acquired. The results of this audit will provide a snap shot of vitamin D status in patients from the South-East London area by age, sex, ethnicity and BMI (weight in kg/height2). Correlation analysis will also be undertaken with other laboratory parameters.
January-June 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collecting Covid-19 screening results together with age, sex, ethnicity and BMI and other relevant laboratory results.
Time Frame: March-June 2020

All Covid-19 screening results together with vitamin D (nmol/L), ethnicity, age (yrs), weight (m) and height to obtain BMI, length of stay in hospital including ICU in days (if applicable), type of illness, recovered or not (y or no), 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 will be collected from patients tested at GSTT NHS Trust.

We 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.
March-June 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Principal Investigator: Agata Sobczynska-Malefora, PhD, GSTT NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2020

Primary Completion (ACTUAL)

January 30, 2021

Study Completion (ACTUAL)

March 31, 2021

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (ACTUAL)

August 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 285176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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