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

NCT04476680 | Unknown

• 1 other identifier: 1070MODREC20
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 2

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. 1.Any effect of vitamin D status on symptomatic illness.
2. 2.The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.
3. 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. 4.Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method
5. 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Seroconversion

  asymptomatic seroconversion for SARS-CoV-2

  24 weeks

• Interim analysis - seropositivity at 12 weeks

  asymptomatic seroconversion for SARS-CoV-2

  12 weeks

Secondary Outcomes (5)

• Dried Blood Spot performance

  24 weeks

• Salivary IgA performance

  24 weeks

• Prevalence of SARS-CoV-2

  24 weeks

• Change in seropositivity

  24 weeks

• Change in seroconversion rate

  24 weeks

Study Arms (2)

Military recruits

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D

No intervention

NO INTERVENTION

Interventions

Vitamin D DIETARY_SUPPLEMENT

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

Also known as: Pure Encapsulations, Sudbury, MA, USA

Military recruits

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Centre for Defence Medicine: lead
• Leeds Beckett University: collaborator
• Liverpool John Moores University: collaborator

Study Sites (2)

Headingley and City campuses, Leeds Beckett University

Leeds, Yorkshire, LS6 3QQ, United Kingdom

NOT YET RECRUITING

Infantry Training Centre Catterick

Catterick Garrison, DL9 4HH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; Vitamin D Deficiency; COVID-19

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• David R Woods, MD

  Royal Centre of Defence Medicine, Birmingham, UK

  STUDY CHAIR

• Julie P Greeves, PhD

  Army Health and Performance Research, Andover, UK

  PRINCIPAL INVESTIGATOR

• Neil Walsh, PhD

  Liverpool John Moores University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David R Woods, MD

CONTACT

00441214158660; doctordrwoods@aol.com

John O'Hara, PhD

CONTACT

00441138125239; J.OHara@leedsbeckett.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 20, 2020
• Study Start: September 1, 2020
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)