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NCT05290298 Clinical Trial

Nitrate-based Nutritional Formula for Oxygen Saturation and Patient-reported Outcomes in Covid-19

COVID-19 Clinical Trial

— COVID-NITRA  

Official title:
Short-term Intervention With Nitrate-based Nutritional Formula on Oxygen Saturation and Patient-reported Outcomes in Covid-19 Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05290298
Other study ID # 02-TLI/2021-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date February 15, 2022

Study information
Verified date May 2022
Source University of Novi Sad, Faculty of Sport and Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date February 15, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• NITRATE
Multi-component nutritional formula
• PLACEBO
Placebo

Locations
Country Name City State
Serbia Applied Bioenergetics Lab at Faculty of Sport and PE Novi Sad Vojvodina

Sponsors (1)
Lead Sponsor Collaborator
University of Novi Sad, Faculty of Sport and Physical Education

Country where clinical trial is conducted

Serbia, 

References & Publications (1)

Ostojic SM, Milovancev A, Drid P, Nikolaidis A. Oxygen saturation improved with nitrate-based nutritional formula in patients with COVID-19. J Int Med Res. 2021 Apr;49(4):3000605211012380. doi: 10.1177/03000605211012380. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in oxygen saturation Measured at baseline and 72 hours post-intervention Baseline vs. 72 hours post-intervention
Secondary Change in fatigue Measured at baseline and 72 hours post-intervention Baseline vs. 72 hours post-intervention
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