Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
4400

Summary

Conditions
  • Acute Respiratory Tract Infection
  • COVID-19
  • SARS-CoV Infection
  • Vitamin D Deficiency
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention 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

Participation Requirements

Age
Between 18 years and 30 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT04476680
Collaborators
  • Leeds Beckett University
  • Liverpool John Moores 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