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| Name | Class |
|---|---|
| Leeds Beckett University | OTHER |
| Liverpool John Moores University | OTHER |
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This study is intended to address the association between vitamin D status and seroconversion to SARS-CoV-2 in healthy young adults.
The primary aim of the study is to determine the rates of 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population with a wide spread of vitamin D concentrations.
The secondary aims of this study are to explore:
The primary aim of the study is to determine the rates of 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population with a wide spread of vitamin D concentrations.
The study will be conducted over 16 weeks in two populations: Service Personnel undertaking initial military training, who are supplementing with vitamin D (1000 IU/day D3 for 4 weeks, and 400 IU/d D3 as a maintenance dose), and civilian students who are not supplementing.
We will recruit adults aged 18-30 years old. Military and civilian participants will be recruited respectively in Catterick and Leeds, UK to start in coincidence with the recommencement of Autumn semester.
In accordance with our power calculation and anticipated drop-out rate, 450 volunteers will be recruited in each group. Data collected at baseline and after 5, 9, 12 and 16 weeks will include seroconversion status assessed from a validated Dried Blood Spot (DBS) method in conjunction with novel salivary antibody testing, plus structured questionnaire responses screening for Covid-19 symptoms. Physical and demographic characteristics and serum levels of vitamin D concentrations collected from participants at study entry will facilitate secondary aims in relation to exploring the influence of gender, ethnicity, body mass and body mass index (BMI) on asymptomatic seroconversion, as well as interactions with vitamin D status and supplementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Military recruits | Active Comparator | Vitamin D supplementation (1000 IU/day D3 for 4 weeks, and 400 IU/d D3 as a maintenance dose) |
|
| No intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | Pure Encapsulations' manufacturing facility is a US Food and Drug Administration (FDA) inspected and NSF International Good Manufacturing Practices registered company. |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion | asymptomatic seroconversion for SARS-CoV-2 | 24 weeks |
| Interim analysis - seropositivity at 12 weeks | asymptomatic seroconversion for SARS-CoV-2 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dried Blood Spot performance | Sensitivity and specificity of dried blood spot assay compared with venous blood serology | 24 weeks |
| Salivary IgA performance | Sensitivity and specificity of salivary IgA compared with venous blood serology |
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Inclusion Criteria:
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
Condition conferring 'very high risk' or 'high risk' of severe COVID-19
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David R Woods, MD | Contact | 00441214158660 | doctordrwoods@aol.com | |
| John O'Hara, PhD | Contact | 00441138125239 | J.OHara@leedsbeckett.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| David R Woods, MD | Royal Centre of Defence Medicine, Birmingham, UK | Study Chair |
| Julie P Greeves, PhD | Army Health and Performance Research, Andover, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Headingley and City campuses, Leeds Beckett University | Not yet recruiting | Leeds | Yorkshire | LS6 3QQ | United Kingdom |
Anonymised IPD may be available upon request
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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D014808 | Vitamin D Deficiency |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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Observational study in two cohorts, matched for age and latitude. One group will be taking vitamin D supplements.
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|
| 24 weeks |
| Prevalence of SARS-CoV-2 | The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults. | 24 weeks |
| Change in seropositivity | The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time | 24 weeks |
| Change in seroconversion rate | The effect of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' statusÍž ii) extent of BMI-defined normal/overweight/obesity cut-offs, iii) gender iv) ethnicity | 24 weeks |
| Neil Walsh, PhD |
| Liverpool John Moores University |
| Principal Investigator |
| Infantry Training Centre Catterick | Recruiting | Catterick Garrison | DL9 4HH | United Kingdom |
|
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |