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

University of Novi Sad, Faculty of Sport and Physical Education52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

COVID-19

Interventions

NITRATEDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in oxygen saturation

Measured at baseline and 72 hours post-intervention

Time frame: Baseline vs. 72 hours post-intervention

Secondary Outcomes

Change in fatigue