Back to results

Influence of Military Preventive Policy for reCruit Training on COVID-19 Seroconversion (IMPACTCOVID)

Primary Purpose

SARS-CoV Infection, Vitamin D Deficiency, Covid19

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Vitamin D

About this trial

This is an interventional prevention trial for SARS-CoV Infection focused on measuring SARS-CoV-2, Cholecalciferol, Vitamin D Status, COVID-19, Acute Respiratory Tract Infection

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

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
- 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)

Sites / Locations

Headingley and City campuses, Leeds Beckett University
Infantry Training Centre CatterickRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Military recruits

No intervention

Arm Description

Vitamin D supplementation (1000 IU/day D3 for 4 weeks, and 400 IU/d D3 as a maintenance dose)

Outcomes

Primary Outcome Measures

Seroconversion

asymptomatic seroconversion for SARS-CoV-2

Interim analysis - seropositivity at 12 weeks

asymptomatic seroconversion for SARS-CoV-2

Secondary Outcome Measures

Dried Blood Spot performance

Sensitivity and specificity of dried blood spot assay compared with venous blood serology

Salivary IgA performance

Sensitivity and specificity of salivary IgA compared with venous blood serology

Prevalence of SARS-CoV-2

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

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

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

Full Information

NCT ID

NCT04476680

First Posted

July 16, 2020

Last Updated

March 19, 2021

Sponsor

Royal Centre for Defence Medicine

Collaborators

Leeds Beckett University, Liverpool John Moores University

1. Study Identification

Unique Protocol Identification Number

NCT04476680

Brief Title

Influence of Military Preventive Policy for reCruit Training on COVID-19 Seroconversion

Acronym

IMPACTCOVID

Official Title

Influence of Military Preventive Policy for reCruit Training on COVID-19 Seroconversion

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

April 28, 2021 (Anticipated)

Study Completion Date

April 28, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royal Centre for Defence Medicine

Collaborators

Leeds Beckett University, Liverpool John Moores University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS-CoV Infection, Vitamin D Deficiency, Covid19, Acute Respiratory Tract Infection

Keywords

SARS-CoV-2, Cholecalciferol, Vitamin D Status, COVID-19, Acute Respiratory Tract Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Observational study in two cohorts, matched for age and latitude. One group will be taking vitamin D supplements.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Military recruits

Arm Type

Active Comparator

Arm Description

Vitamin D supplementation (1000 IU/day D3 for 4 weeks, and 400 IU/d D3 as a maintenance dose)

Arm Title

No intervention

Arm Type

No Intervention

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Other Intervention Name(s)

Pure Encapsulations, Sudbury, MA, USA

Intervention Description

Pure Encapsulations' manufacturing facility is a US Food and Drug Administration (FDA) inspected and NSF International Good Manufacturing Practices registered company.

Primary Outcome Measure Information:

Title

Seroconversion

Description

asymptomatic seroconversion for SARS-CoV-2

Time Frame

24 weeks

Title

Interim analysis - seropositivity at 12 weeks

Description

asymptomatic seroconversion for SARS-CoV-2

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Dried Blood Spot performance

Description

Sensitivity and specificity of dried blood spot assay compared with venous blood serology

Time Frame

24 weeks

Title

Salivary IgA performance

Description

Sensitivity and specificity of salivary IgA compared with venous blood serology

Time Frame

24 weeks

Title

Prevalence of SARS-CoV-2

Description

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

Time Frame

24 weeks

Title

Change in seropositivity

Description

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

Time Frame

24 weeks

Title

Change in seroconversion rate

Description

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David R Woods, MD

Phone

00441214158660

doctordrwoods@aol.com

First Name & Middle Initial & Last Name or Official Title & Degree

John O'Hara, PhD

Phone

00441138125239

J.OHara@leedsbeckett.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David R Woods, MD

Organizational Affiliation

Royal Centre of Defence Medicine, Birmingham, UK

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Julie P Greeves, PhD

Organizational Affiliation

Army Health and Performance Research, Andover, UK

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Neil Walsh, PhD

Organizational Affiliation

Liverpool John Moores University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Headingley and City campuses, Leeds Beckett University

City

Leeds

State/Province

Yorkshire

ZIP/Postal Code

LS6 3QQ

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

John O'Hara, PhD

Phone

00441138125239

J.OHara@leedsbeckett.ac.uk

Facility Name

Infantry Training Centre Catterick

City

Catterick Garrison

ZIP/Postal Code

DL9 4HH

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fiona Koivula, PhD

Phone

00447462817020

fiona.koivula928@mod.gov.uk

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Anonymised IPD may be available upon request

Learn more about this trial

Influence of Military Preventive Policy for reCruit Training on COVID-19 Seroconversion

We'll reach out to this number within 24 hrs