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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386044
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Tameside General Hospital

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.


Condition or disease
COVID-19 Vitamin D Deficiency

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Other
Official Title: Investigating the Role of Vitamin D in the Morbidity of COVID-19 Patients
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. COVID-19 infection [ Time Frame: 1 year ]
    Development of COVID-19 during case-control study

  2. Oxygen therapy for COVID-19 [ Time Frame: 1 year ]
    Whether hospitalised COVID-19 patients require oxygen therapy

  3. Discharge following COVID-19 hospitalisation [ Time Frame: 1 year ]
    Whether patients hospitalised with COVID-19 were discharged

  4. Death due to COVID-19 [ Time Frame: 1 year ]
    Whether patients hospitalised with COVID-19 died in hospital


Biospecimen Retention:   Samples Without DNA
Serum blood samples to be analysed for serum vitamin D levels


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Criteria

ARM 1 - hospital in-patients

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Final clinical diagnosis NOT COVID-19.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386044


Contacts
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Contact: Edward Jude, MD +441619225189 edward.jude@tgh.nhs.uk
Contact: Rebecca Roberts +441619224451 rebecca.roberts@tgh.nhs.uk

Locations
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United Kingdom
Tameside Hospital NHS Foundation Trust
Ashton-under-Lyne, Greater Manchester, United Kingdom, OL6 9RW
Sponsors and Collaborators
Tameside General Hospital
Investigators
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Study Director: Margaret Cooper Tameside and Glossop Integrated Care NHS Foundation Trust
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Responsible Party: Tameside General Hospital
ClinicalTrials.gov Identifier: NCT04386044    
Other Study ID Numbers: TGH1234
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tameside General Hospital:
COVID-19
SARS-CoV-2
Novel coronavirus
Vitamin D
Ethnicity
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders