Nitrate-based Nutritional Formula for Oxygen Saturation and Patient-reported Outcomes in Covid-19 (COVID-NITRA)
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
NITRATE
PLACEBO
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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
Sites / Locations
- Applied Bioenergetics Lab at Faculty of Sport and PE
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NITRATE
PLACEBO
Arm 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)
Placebo (2.5 grams of inulin)
Outcomes
Primary Outcome Measures
Change in oxygen saturation
Measured at baseline and 72 hours post-intervention
Secondary Outcome Measures
Change in fatigue
Measured at baseline and 72 hours post-intervention
Full Information
NCT ID
NCT05290298
First Posted
March 21, 2022
Last Updated
May 17, 2022
Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
1. Study Identification
Unique Protocol Identification Number
NCT05290298
Brief Title
Nitrate-based Nutritional Formula for Oxygen Saturation and Patient-reported Outcomes in Covid-19
Acronym
COVID-NITRA
Official Title
Short-term Intervention With Nitrate-based Nutritional Formula on Oxygen Saturation and Patient-reported Outcomes in Covid-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NITRATE
Arm Type
Experimental
Arm 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)
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
Placebo (2.5 grams of inulin)
Intervention Type
Dietary Supplement
Intervention Name(s)
NITRATE
Intervention Description
Multi-component nutritional formula
Intervention Type
Dietary Supplement
Intervention Name(s)
PLACEBO
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in oxygen saturation
Description
Measured at baseline and 72 hours post-intervention
Time Frame
Baseline vs. 72 hours post-intervention
Secondary Outcome Measure Information:
Title
Change in fatigue
Description
Measured at baseline and 72 hours post-intervention
Time Frame
Baseline vs. 72 hours post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Applied Bioenergetics Lab at Faculty of Sport and PE
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33906526
Citation
Ostojic SM, Milovancev A, Drid P, Nikolaidis A. Oxygen saturation improved with nitrate-based nutritional formula in patients with COVID-19. J Int Med Res. 2021 Apr;49(4):3000605211012380. doi: 10.1177/03000605211012380.
Results Reference
background
Learn more about this trial
Nitrate-based Nutritional Formula for Oxygen Saturation and Patient-reported Outcomes in Covid-19
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