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Investigation of the Effects of Dietary Nitrate and Sex on COVID-19 Vaccine Induced Vascular Dysfunction in Healthy Men and Women (DiNOVasc-COVID-19)

StatusCompleted
PhasePhase 1
Started
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Record History

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  1. Trial completed Show 5 more changesShow less
    • Final enrollment: 42 participants (planned 98)
    • Primary completion date changed from estimate of Apr 30, 2026 to Dec 2, 2025
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Publications: details revised at 4 of 4 entries
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
  3. Trial status: Active, Not Recruiting to Recruiting
    • Primary and study completion dates: Dec 30, 2024 to Apr 30, 2026
    • Site details revised
    v6
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  5. Primary completion date: Mar 30, 2023 to Dec 30, 2024
    • Study completion date: Dec 30, 2023 to Dec 30, 2024
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Dec 30, 2022 to Mar 30, 2023
    • Study completion date: Dec 30, 2022 to Dec 30, 2023
    v3
  2. Primary completion date: Aug 1, 2021 to Dec 30, 2022
    • Study completion date: May 10, 2022 to Dec 30, 2022
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 the suppression of inflammatory pathways. Whether this protection against inflammation-induced damage to the blood vessel wall might also be functional in the setting of COVID-19 vaccination will be investigated. Vascular function will be assessed before and after the healthy participant has received their COVID-19-vaccination. Whether there might be differences in the response to the vaccine between the sexes and whether a dietary nitrate intervention impacts upon the effects of vaccination will be investigated. The study is in two parts: Part A: To assess sex differences in the vascular response to COVID-19 vaccination. Part B: To assess whether inorganic nitrate, in the form of dietary inorganic nitrate supplementation compared to placebo control, can raise circulating plasma nitrite levels and thereby prevent the systemic inflammation that causes vascular dysfunction.
Trial Details
NCT Number NCT04889274
Lead Sponsor Queen Mary University of London
Conditions
(from sponsor)		 Cardiovascular Diseases, Endothelial Dysfunction
Related terms Cardiovascular Diseases, Coitus, COVID-19
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov