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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• COVID-19

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