Investigating the Role of Vitamin D in the Morbidity of COVID-19 Patients
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ClinicalTrials.gov Identifier: NCT04386044 |
Recruitment Status :
Completed
First Posted : May 13, 2020
Last Update Posted : May 7, 2021
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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 |
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COVID-19 Vitamin D Deficiency |

Study Type : | Observational |
Actual Enrollment : | 986 participants |
Observational Model: | Other |
Time Perspective: | Other |
Official Title: | Investigating the Role of Vitamin D in the Morbidity of COVID-19 Patients |
Actual Study Start Date : | June 1, 2020 |
Actual Primary Completion Date : | August 8, 2020 |
Actual Study Completion Date : | September 8, 2020 |

Group/Cohort |
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Hospital in-patients
Cross-sectional study of hospital in-patients admitted with COVID-19 n=200
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Controls (case-control study arm)
Case-control study of n=800 patients prospectively recruited from primary care
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Cases (case-control study arm)
Case-control study of n=800 patients prospectively recruited from primary care
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- COVID-19 infection [ Time Frame: 1 year ]Development of COVID-19 during case-control study
- Oxygen therapy for COVID-19 [ Time Frame: 1 year ]Whether hospitalised COVID-19 patients require oxygen therapy
- Discharge following COVID-19 hospitalisation [ Time Frame: 1 year ]Whether patients hospitalised with COVID-19 were discharged
- Death due to COVID-19 [ Time Frame: 1 year ]Whether patients hospitalised with COVID-19 died in hospital
Biospecimen Retention: Samples Without DNA

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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 |
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.
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.

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
United Kingdom | |
Tameside Hospital NHS Foundation Trust | |
Ashton-under-Lyne, Greater Manchester, United Kingdom, OL6 9RW |
Study Director: | Margaret Cooper | Tameside and Glossop Integrated Care NHS Foundation Trust |
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 7, 2021 |
Last Verified: | May 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 SARS-CoV-2 Novel coronavirus Vitamin D Ethnicity |
COVID-19 Vitamin D Deficiency Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |