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Completed

NCT Number: NCT05290298

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitrate

Dietary Supplement

Multi-component nutritional formula

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Change in oxygen saturation

    Time frame: Baseline vs. 72 hours post-intervention

    Measured at baseline and 72 hours post-intervention

Secondary outcomes

  1. Change in fatigue

    Time frame: Baseline vs. 72 hours post-intervention

    Measured at baseline and 72 hours post-intervention

Sponsors and collaborators

Lead sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Other

Registry information

Official study title

Short-term Intervention With Nitrate-based Nutritional Formula on Oxygen Saturation and Patient-reported Outcomes in Covid-19 Patients

Acronym: COVID-NITRA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2022
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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