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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04476680 on ClinicalTrials.gov