Reducing Asymptomatic Infection With Vitamin D in Coronavirus Disease

• Status: Not yet recruiting
• Trial end date: 2021-04-28
• Target enrollment: 4400
• Participant gender: All

Summary

This study is intended to address whether oral daily vitamin D supplementation reduces infection with SARS-CoV-2 in healthy young adults.

The primary aim of the study is to demonstrate a reduction in 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population following 24 weeks of taking oral vitamin D supplemented at a dose of 1000 I.U. daily, versus matching placebo.

The secondary aims of this study are to explore:

1. Any effect on symptomatic illness.

2. The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.

3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time.

4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method

5. The effect (if any) of vitamin D supplementation on seroconversion rates stratified by:

i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Royal Centre for Defence Medicine
• Collaborators: Leeds Beckett University; University of Nottingham
• Treatments: Vitamin D

Criteria

Inclusion Criteria:

• Able to access the study sites at Leeds Beckett University's Headingley or City campuses, UK.

• In possession of an internet-enabled smart phone capable of receiving and responding to smartphone alerts.

Exclusion Criteria:

• Previously diagnosed with COVID-19 either by RT-PCR or serologically (either prior to the study or at initial baseline testing).

• Use of over-the-counter or prescribed vitamin D supplements currently or in the past month

• Potential participants who are vegans will also be excluded since the study will use vitamin D3 derived from lanolin which, while acceptable to vegetarians is not acceptable to vegans.

• Condition conferring 'very high risk' or 'high risk' of severe COVID-19

• have had an organ transplant

• are having chemotherapy or antibody treatment for cancer, including immunotherapy

• are having an intense course of radiotherapy (radical radiotherapy) for lung cancer

• are having targeted cancer treatments that can affect the immune system (such as protein kinase inhibitors or PARP inhibitors)

• have blood or bone marrow cancer (such as leukaemia, lymphoma or myeloma)

• have had a bone marrow or stem cell transplant in the past 6 months, or are still taking immunosuppressant medicine

• are pregnant or intent on becoming pregnant during the anticipated study period

• have a learning disability

• have a lung condition (such as cystic fibrosis, asthma, COPD, emphysema or bronchitis)

• have heart disease (such as heart failure)

• have high blood pressure (hypertension)

• have diabetes

• have chronic kidney disease

• have liver disease (such as hepatitis)

• have a condition affecting the brain or nerves (such as Parkinson's disease, motor neurone disease, multiple sclerosis, or cerebral palsy)

• have a problem with the spleen or have had the spleen removed

• have a condition with high risk of getting infections (such as SCID, sickle cell, HIV, lupus or scleroderma)

• are taking medicine that can affect the immune system (such as steroids)

• are very obese (a BMI of 40 or above)