Influence of Military Preventive Policy for reCruit Training on COVID-19 Seroconversion
NCT04476680 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900
Last updated 2021-03-23
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.
Conditions
- SARS-CoV Infection
- Vitamin D Deficiency
- Covid19
- Acute Respiratory Tract Infection
Interventions
- 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.
Sponsors & Collaborators
-
Leeds Beckett University
collaborator OTHER -
Liverpool John Moores University
collaborator OTHER -
Royal Centre for Defence Medicine
lead OTHER_GOV
Principal Investigators
-
David R Woods, MD · Royal Centre of Defence Medicine, Birmingham, UK
-
Julie P Greeves, PhD · Army Health and Performance Research, Andover, UK
-
Neil Walsh, PhD · Liverpool John Moores University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-09-01
- Primary Completion
- 2021-04-28
- Completion
- 2021-04-28
Countries
- United Kingdom
Study Locations
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