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

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ClinicalTrials.gov Identifier: NCT04476680
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : March 23, 2021
Sponsor:
Collaborators:
Leeds Beckett University
Liverpool John Moores University
Information provided by (Responsible Party):
Royal Centre for Defence Medicine

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:

  1. Any effect of vitamin D status 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.

Condition or disease Intervention/treatment Phase
SARS-CoV Infection Vitamin D Deficiency Covid19 Acute Respiratory Tract Infection Dietary Supplement: Vitamin D Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : September 1, 2020
Estimated Primary Completion Date : April 28, 2021
Estimated Study Completion Date : April 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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 Name: Pure Encapsulations, Sudbury, MA, USA

No Intervention: No intervention



Primary Outcome Measures :
  1. Seroconversion [ Time Frame: 24 weeks ]
    asymptomatic seroconversion for SARS-CoV-2

  2. Interim analysis - seropositivity at 12 weeks [ Time Frame: 12 weeks ]
    asymptomatic seroconversion for SARS-CoV-2


Secondary Outcome Measures :
  1. Dried Blood Spot performance [ Time Frame: 24 weeks ]
    Sensitivity and specificity of dried blood spot assay compared with venous blood serology

  2. Salivary IgA performance [ Time Frame: 24 weeks ]
    Sensitivity and specificity of salivary IgA compared with venous blood serology

  3. Prevalence of SARS-CoV-2 [ Time Frame: 24 weeks ]
    The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.

  4. Change in seropositivity [ Time Frame: 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

  5. Change in seroconversion rate [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476680


Contacts
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Contact: David R Woods, MD 00441214158660 doctordrwoods@aol.com
Contact: John O'Hara, PhD 00441138125239 J.OHara@leedsbeckett.ac.uk

Locations
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United Kingdom
Headingley and City campuses, Leeds Beckett University Not yet recruiting
Leeds, Yorkshire, United Kingdom, LS6 3QQ
Contact: John O'Hara, PhD    00441138125239    J.OHara@leedsbeckett.ac.uk   
Infantry Training Centre Catterick Recruiting
Catterick Garrison, United Kingdom, DL9 4HH
Contact: Fiona Koivula, PhD    00447462817020    fiona.koivula928@mod.gov.uk   
Sponsors and Collaborators
Royal Centre for Defence Medicine
Leeds Beckett University
Liverpool John Moores University
Investigators
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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
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Responsible Party: Royal Centre for Defence Medicine
ClinicalTrials.gov Identifier: NCT04476680    
Other Study ID Numbers: 1070MODREC20
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Anonymised IPD may be available upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royal Centre for Defence Medicine:
SARS-CoV-2
Cholecalciferol
Vitamin D Status
COVID-19
Acute Respiratory Tract Infection
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Respiratory Tract Infections
Severe Acute Respiratory Syndrome
Vitamin D Deficiency
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents