Investigating the Role of Vitamin D in the Morbidity of COVID-19 Patients

NCT04386044 | Completed

• 1 other identifier: TGH1234
• Study Type: observational
• Target: 986
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Vitamin D Deficiency

Keywords

COVID-19; SARS-CoV-2; Novel coronavirus; Vitamin D; Ethnicity

Outcome Measures

Primary Outcomes (4)

• COVID-19 infection

  Development of COVID-19 during case-control study

  1 year

• Oxygen therapy for COVID-19

  Whether hospitalised COVID-19 patients require oxygen therapy

  1 year

• Discharge following COVID-19 hospitalisation

  Whether patients hospitalised with COVID-19 were discharged

  1 year

• Death due to COVID-19

  Whether patients hospitalised with COVID-19 died in hospital

  1 year

Study Arms (3)

Hospital in-patients

Cross-sectional study of hospital in-patients admitted with COVID-19 n=200

Controls (case-control study arm)

Case-control study of n=800 patients prospectively recruited from primary care

Cases (case-control study arm)

Case-control study of n=800 patients prospectively recruited from primary care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ARM 1 Patients will be opportunistically recruited from in-patient admissions with a clinical diagnosis of COVID-19 as registered by the Trust's clinical coding department. This will be carried out at a single centre (Tameside and Glossop Integrated Care NHS Foundation Trust). ARM 2 Patients will be opportunistically recruited from 10 local GP surgeries feeding into the acute Trust, as part of the Tameside and Glossop Clinical Commissioning Group.

You may qualify if:

• 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.

You may not qualify if:

• Final clinical diagnosis NOT COVID-19.
• ARM 2 - prospective primary care case-control study
• Patients on vitamin D treatment to be included, but this will be adjusted for in analysis.
• 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.

Sponsors & Collaborators

• Tameside General Hospital: lead

Study Sites (1)

Tameside Hospital NHS Foundation Trust

Ashton-under-Lyne, Greater Manchester, OL6 9RW, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum blood samples to be analysed for serum vitamin D levels

MeSH Terms

Conditions

COVID-19; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Margaret Cooper

  Tameside and Glossop Integrated Care NHS Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 13, 2020
• Study Start: June 1, 2020
• Primary Completion: August 8, 2020
• Study Completion: September 8, 2020
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

GB (1)