Nitrate-based Nutritional Formula for Oxygen Saturation and Patient-reported Outcomes in Covid-19
Not Applicable
Completed
- Conditions
- COVID-19
- Registration Number
- NCT05290298
- Lead Sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
- Brief Summary
A preliminary open-label case report demonstrated the beneficial effects of an innovative nitrate-based nutritional formula on oxygen saturation in patients with COVID-19. Whether these initial findings are relevant in a more robust research design currently remains unknown. Therefore, the main objective of this randomized controlled trial was to analyze the acute effects of nitrate-based nutritional formula on peripheral SpO2, patient-reported outcomes, and safety indices in patients with acute COVID-19 infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
- age 3 18 years
- confirmed SARS-CoV-2 infection
- SpO2 < 95%
- COVID-19 patients in stable condition (i.e., not requiring hospital admission)
Exclusion Criteria
- regnant or lactating women
- concomitant pulmonary and cardiovascular conditions
- history of dietary supplement use during the past four weeks
- participation in another COVID-19-related study
- unwillingness to give informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in oxygen saturation Baseline vs. 72 hours post-intervention Measured at baseline and 72 hours post-intervention
- Secondary Outcome Measures
Name Time Method Change in fatigue Baseline vs. 72 hours post-intervention Measured at baseline and 72 hours post-intervention
Trial Locations
- Locations (1)
Applied Bioenergetics Lab at Faculty of Sport and PE
🇷🇸Novi Sad, Vojvodina, Serbia
Applied Bioenergetics Lab at Faculty of Sport and PE🇷🇸Novi Sad, Vojvodina, Serbia