Status:
ACTIVE_NOT_RECRUITING
Investigation of the Effects of Dietary Nitrate and Sex on COVID-19 Vaccine Induced Vascular Dysfunction in Healthy Men and Women (DiNOVasc-COVID-19)
Lead Sponsor:
Queen Mary University of London
Conditions:
Cardiovascular Diseases
Endothelial Dysfunction
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Inorganic nitrate can protect blood vessels from the damage that occurs during cardiovascular disease. Early experimental work suggests that nitrate-induced improvements in vascular function relate to...
Detailed Description
Whether the COVID-19 vaccine can be used to study endothelial dysfunction and whether inorganic nitrate might be useful in restoring the function of the endothelium in a scenario simulating the COVID-...
Eligibility Criteria
Inclusion
- Healthy volunteers with a booking for COVID-19 vaccination slot as per government guidelines
- Aged 18-60
- Volunteers who are willing to sign the consent form
Exclusion
- Aged \<18 or \>60 years
- Healthy subjects unwilling to consent
- Pregnant, or any possibility that a subject may be pregnant
- History of any serious illnesses, including recent infections or trauma
- Subjects taking systemic medication (other than the oral contraceptive pill)
- Subjects with self-reported use of mouthwash or tongue scrapes
- Subjects with recent (2 weeks) or current antibiotic use
- Subjects with a history, or recent treatment of (within last 3 months) any oral condition (excluding caries), including gingivitis, periodontitis and halitosis
- Subjects with a history of COVID-19 vaccination
- Subjects with any history of a blood-borne infectious
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT04889274
Start Date
May 10 2021
End Date
April 30 2026
Last Update
August 6 2025
Active Locations (1)
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1
The William Harvey Research Institute
London, United Kingdom, EC1M 6BQ