DiNOVasc-COVID-19 [COVID-19]

• Research type

  Research Study

• Full title

  A double-blind, randomised, placebo-controlled parallel study to investigate the effect of dietary nitrate and sex on COVID-19 vaccine-induced vascular dysfunction in healthy men and women

• IRAS ID

  298309

• Contact name

  Amrita Ahluwalia

• Contact email

  a.ahluwalia@qmul.ac.uk

• Sponsor organisation

  Queen Mary University of London

• Clinicaltrials.gov Identifier

  NCT04889274

• Duration of Study in the UK

  0 years, 11 months, 30 days

• Research summary

  We have previously published work demonstrating that inorganic nitrate can protect blood vessels from the damage that occurs during cardiovascular disease. Our own recent evidence in preclinical models suggests that nitrate-induced improvements in vascular function relate to suppression of inflammatory pathways. We have recently completed a study translating these observations to the clinical setting and the results will be published this year. We now wish to study whether this protection against inflammation-induced damage to the blood vessel wall might also be functional in the setting of COVID-19 vaccination. We will assess vascular function before and after delivery of a COVID-19-vaccine in healthy volunteers. Our previous work suggests important differences between the sexes and we will test whether there might be differences in the response to the vaccine between the sexes too. Inorganic nitrate can be safely administered to humans through the use of commercial supplies of beetroot juice. The study is in two parts:

  The principal research objectives are to determine whether
  Part A) there are sex differences in the vascular response to COVID-19 vaccination

  Part B) whether inorganic nitrate in the form of dietary inorganic nitrate supplementation compared to placebo controls, can raise circulating plasma [NO2-] levels and thereby prevent the systemic inflammation that causes vascular dysfunction

  The study is being undertaken at Queen Mary University London within the William Harvey Heart Centre Clinical Trials Unit and the Centre for Cardiovascular Medicines & Devices at Charterhouse Square, London EC1M 6BQ.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  21/SC/0154

• Date of REC Opinion

  5 May 2021

• REC opinion

  Favourable Opinion