SARS-CoV InfectionIMPACTCOVIDNCT04476680
Influence of Military Preventive Policy for reCruit Training on COVID-19 Seroconversion
A study testing Vitamin D in people with SARS-CoV Infection and Vitamin D Deficiency, run by Royal Centre for Defence Medicine at 2 sites in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection, Vitamin D Deficiency, Covid19
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Sep 2020to 28 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to access the study sites at Leeds Beckett University's Headingley or City campuses, UK OR recruit at Infantry Training Centre, Catterick Garrison, UK
- In possession of an internet-enabled smart phone capable of receiving and responding to smartphone alerts.
Who cannot join
- 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
- 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
Show all 22Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Infantry Training Centre Catterick
Catterick Garrison, DL9 4HH
Fiona Koivula, PhD, 00447462817020, fiona.koivula928@mod.gov.uk
- Not yet recruiting
Headingley and City campuses, Leeds Beckett University
Leeds, Yorkshire, LS6 3QQ
John O'Hara, PhD, 00441138125239, J.OHara@leedsbeckett.ac.uk
About this study
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.
Read more
The secondary aims of this study are to explore:
- Any effect of vitamin D status on symptomatic illness.
- The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.
- The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time.
- Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method
- 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.
Read the detailed description
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.
- Being tested
- Vitamin D
- Keywords
- SARS-CoV-2, Cholecalciferol, Vitamin D Status, COVID-19, Acute Respiratory Tract Infection
- Medical subject headings
- Severe Acute Respiratory Syndrome, Vitamin D Deficiency, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called Pure Encapsulations, Sudbury, MA, USA
Pure Encapsulations' manufacturing facility is a US Food and Drug Administration (FDA) inspected and NSF International Good Manufacturing Practices registered company.
| Study group | Role | What they receive |
|---|---|---|
| Military recruits | Active comparator | Vitamin D supplementation (1000 IU/day D3 for 4 weeks, and 400 IU/d D3 as a maintenance dose) Receives: Dietary Supplement: Vitamin D |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion
asymptomatic seroconversion for SARS-CoV-2
Measured: 24 weeks
Interim analysis - seropositivity at 12 weeks
asymptomatic seroconversion for SARS-CoV-2
Measured: 12 weeks
Secondary outcomes (5)
Dried Blood Spot performance
Sensitivity and specificity of dried blood spot assay compared with venous blood serology
Measured: 24 weeks
Salivary IgA performance
Sensitivity and specificity of salivary IgA compared with venous blood serology
Measured: 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.
Measured: 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
Measured: 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' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs, iii) gender iv) ethnicity
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Sep 2020
- Primary completion28 Apr 2021 (estimated)
- Study completion28 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Observational study in two cohorts, matched for age and latitude. One group will be taking vitamin D supplements.
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Centre for Defence Medicine
- Sponsor type
- Other government
- Collaborators
- Leeds Beckett University, Liverpool John Moores University
- Responsible party
- Sponsor
- Investigators
- David R Woods, MD, Study chair, Royal Centre of Defence Medicine, Birmingham, UKJulie P Greeves, PhD, Principal investigator, Army Health and Performance Research, Andover, UKNeil Walsh, PhD, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476680
- Sponsor's protocol ID
- 1070MODREC20
- Acronym
- IMPACTCOVID
- Status last verified
- Mar 2021
- First submitted
- 16 Jul 2020
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised IPD may be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Military Preventive Policy for reCruit Training on COVID-19 Seroconversion
- ClinicalTrials.gov ID
- NCT04476680
- Acronym / sponsor ID
- IMPACTCOVID / 1070MODREC20
- Keywords
- SARS-CoV-2, Cholecalciferol, Vitamin D Status, COVID-19, Acute Respiratory Tract Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Royal Centre for Defence MedicineOther government
- Collaborators
- Leeds Beckett University, Liverpool John Moores University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 28 Apr 2021 (estimated)
- Study completion
- 28 Apr 2021 (estimated)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Any effect of vitamin D status on symptomatic illness.
- The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.
- The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time.
- Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method
- 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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Observational study in two cohorts, matched for age and latitude. One group will be taking vitamin D supplements.
| Arm | Type | Receives |
|---|---|---|
| Military recruits | Active comparator | Dietary Supplement: Vitamin DVitamin D supplementation (1000 IU/day D3 for 4 weeks, and 400 IU/d D3 as a maintenance dose) |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Able to access the study sites at Leeds Beckett University's Headingley or City campuses, UK OR recruit at Infantry Training Centre, Catterick Garrison, UK
- In possession of an internet-enabled smart phone capable of receiving and responding to smartphone alerts.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: Pure Encapsulations, Sudbury, MA, USAPure Encapsulations' manufacturing facility is a US Food and Drug Administration (FDA) inspected and NSF International Good Manufacturing Practices registered company. | Dietary supplement | Military recruits |
Primary outcome
Seroconversion
Time frame: 24 weeks
asymptomatic seroconversion for SARS-CoV-2
Interim analysis - seropositivity at 12 weeks
Time frame: 12 weeks
asymptomatic seroconversion for SARS-CoV-2
5 secondary outcomes
Dried Blood Spot performance
Time frame: 24 weeks
Salivary IgA performance
Time frame: 24 weeks
Prevalence of SARS-CoV-2
Time frame: 24 weeks
Change in seropositivity
Time frame: 24 weeks
Change in seroconversion rate
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: No. Anonymised IPD may be available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Woods, MD study chair
Royal Centre of Defence Medicine, Birmingham, UK
Julie P Greeves, PhD principal investigator
Army Health and Performance Research, Andover, UK
Neil Walsh, PhD principal investigator
Liverpool John Moores University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with SARS-CoV Infection and Vitamin D Deficiency, run by Royal Centre for Defence Medicine at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David R Woods, MD (00441214158660, doctordrwoods@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.