Nitrate-based Nutritional Formula for Oxygen Saturation and Patient-reported Outcomes in Covid-19 (COVID-NITRA)

University of Novi Sad, Faculty of Sport and Physical Education

Status: Completed

Conditions: COVID-19

Treatments: Dietary Supplement: PLACEBO; Dietary Supplement: NITRATE

Study type: Interventional

Funder types: Other

Identifiers

NCT05290298

02-TLI/2021-2

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups, including a placebo group

NITRATE

Experimental group

Description:

Multi-component nutritional formula (containing 1200 mg of potassium nitrate, 200 mg of magnesium, 50 mg of zinc, and 1000 mg of citric acid)

Treatment:

Dietary Supplement: NITRATE

PLACEBO

Placebo Comparator group

Description:

Placebo (2.5 grams of inulin)

Treatment:

Dietary Supplement: PLACEBO