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

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Dietary Supplement: NITRATE; Dietary Supplement: PLACEBO

• 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

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-15
• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-22
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24

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

Arm && Interventions

Group	Intervention	Description
NITRATE	NITRATE	Multi-component nutritional formula (containing 1200 mg of potassium nitrate, 200 mg of magnesium, 50 mg of zinc, and 1000 mg of citric acid)
PLACEBO	PLACEBO	Placebo (2.5 grams of inulin)

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