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

Sponsor

Royal Centre for Defence Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04476680

Collaborator

Leeds Beckett University (Other), Liverpool John Moores University (Other)

900

Enrollment

Locations

Arms

7.9

Anticipated Duration (Months)

450

Patients Per Site

57.3

Patients Per Site Per Month

Study Details

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:

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

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV Infection Vitamin D Deficiency Covid19 Acute Respiratory Tract Infection	Dietary Supplement: Vitamin D	N/A

Detailed Description

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

Study Type:

Interventional

Anticipated Enrollment :

900 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Apr 28, 2021

Anticipated Study Completion Date :

Apr 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Military recruits Vitamin D supplementation (1000 IU/day D3 for 4 weeks, and 400 IU/d D3 as a maintenance dose)	Dietary Supplement: Vitamin D Pure Encapsulations' manufacturing facility is a US Food and Drug Administration (FDA) inspected and NSF International Good Manufacturing Practices registered company. Other Names: Pure Encapsulations, Sudbury, MA, USA
No Intervention: No intervention

Arm

Intervention/Treatment

Active Comparator: Military recruits

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

Dietary Supplement: Vitamin D

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

Other Names:

Pure Encapsulations, Sudbury, MA, USA

No Intervention: No intervention

Outcome Measures

Primary Outcome Measures

Seroconversion [24 weeks]
asymptomatic seroconversion for SARS-CoV-2
Interim analysis - seropositivity at 12 weeks [12 weeks]
asymptomatic seroconversion for SARS-CoV-2

Secondary Outcome Measures

Dried Blood Spot performance [24 weeks]
Sensitivity and specificity of dried blood spot assay compared with venous blood serology
Salivary IgA performance [24 weeks]
Sensitivity and specificity of salivary IgA compared with venous blood serology
Prevalence of SARS-CoV-2 [24 weeks]
The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.
Change in seropositivity [24 weeks]
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 [24 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Headingley and City campuses, Leeds Beckett University	Leeds	Yorkshire	United Kingdom	LS6 3QQ
2	Infantry Training Centre Catterick	Catterick Garrison		United Kingdom	DL9 4HH

Sponsors and Collaborators

Royal Centre for Defence Medicine
Leeds Beckett University
Liverpool John Moores University

Investigators

Study Chair: David R Woods, MD, Royal Centre of Defence Medicine, Birmingham, UK
Principal Investigator: Julie P Greeves, PhD, Army Health and Performance Research, Andover, UK
Principal Investigator: Neil Walsh, PhD, Liverpool John Moores University