COVID-19
Conditions
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.
Interventions
DIETARY_SUPPLEMENTNITRATE
Multi-component nutritional formula
DIETARY_SUPPLEMENTPLACEBO
Placebo
Sponsors
University of Novi Sad, Faculty of Sport and Physical Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in oxygen saturation | Baseline vs. 72 hours post-intervention | Measured at baseline and 72 hours post-intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fatigue | Baseline vs. 72 hours post-intervention | Measured at baseline and 72 hours post-intervention |
Countries
Serbia
Outcome results
None listed