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

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.

Study Overview

• Status: Unknown
• Conditions: Covid19; Vitamin D Deficiency; SARS-CoV Infection; Acute Respiratory Tract Infection
• Intervention / Treatment: Dietary supplement: Vitamin D

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 Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David R Woods, MD; Phone Number: 00441214158660; Email: doctordrwoods@aol.com
• Study Contact Backup: Name: John O'Hara, PhD; Phone Number: 00441138125239; Email: J.OHara@leedsbeckett.ac.uk

Study Locations

• United Kingdom
  • Catterick Garrison, United Kingdom, DL9 4HH
    • Recruiting
    • Infantry Training Centre Catterick
    • Contact: Fiona Koivula, PhD; Phone Number: 00447462817020; Email: fiona.koivula928@mod.gov.uk
  • Yorkshire
    • Leeds, Yorkshire, United Kingdom, LS6 3QQ
      • Not yet recruiting
      • Headingley and City campuses, Leeds Beckett University
      • Contact: John O'Hara, PhD; Phone Number: 00441138125239; Email: J.OHara@leedsbeckett.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs, iii) gender iv) ethnicity	24 weeks

Collaborators and Investigators

• Sponsor: Royal Centre for Defence Medicine
• Collaborators: Liverpool John Moores University; Leeds Beckett 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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): April 28, 2021
• Study Completion (Anticipated): April 28, 2021

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Cholecalciferol; Vitamin D Status; Acute Respiratory Tract Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Severe Acute Respiratory Syndrome; COVID-19; Infections; Communicable Diseases; Vitamin D Deficiency; Respiratory Tract Infections; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 1070MODREC20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymised IPD may be available upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No