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

May 17, 2022 updated by: Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Applied Bioenergetics Lab at Faculty of Sport and PE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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)
Dietary supplement: NITRATE
Multi-component nutritional formula
PLACEBO_COMPARATOR: PLACEBO
Placebo (2.5 grams of inulin)
Dietary supplement: PLACEBO
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in oxygen saturation
Time Frame: Baseline vs. 72 hours post-intervention
Measured at baseline and 72 hours post-intervention
Baseline vs. 72 hours post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fatigue
Time Frame: Baseline vs. 72 hours post-intervention
Measured at baseline and 72 hours post-intervention
Baseline vs. 72 hours post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2021

Primary Completion (ACTUAL)

February 1, 2022

Study Completion (ACTUAL)

February 15, 2022

Study Registration Dates

First Submitted

March 21, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (ACTUAL)

March 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-TLI/2021-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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