Nitrate-based Nutritional Formula for Oxygen Saturation and Patient-reported Outcomes in Covid-19
COVID-NITRA
Short-term Intervention With Nitrate-based Nutritional Formula on Oxygen Saturation and Patient-reported Outcomes in Covid-19 Patients
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2022
CompletedFirst Submitted
Initial submission to the registry
March 21, 2022
CompletedFirst Posted
Study publicly available on registry
March 22, 2022
CompletedMay 24, 2022
May 1, 2022
5 months
March 21, 2022
May 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in oxygen saturation
Measured at baseline and 72 hours post-intervention
Baseline vs. 72 hours post-intervention
Secondary Outcomes (1)
Change in fatigue
Baseline vs. 72 hours post-intervention
Study Arms (2)
NITRATE
EXPERIMENTALMulti-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 COMPARATORPlacebo (2.5 grams of inulin)
Interventions
Eligibility Criteria
You may qualify if:
- age 3 18 years
- confirmed SARS-CoV-2 infection
- SpO2 \< 95%
- COVID-19 patients in stable condition (i.e., not requiring hospital admission)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, 21000, Serbia
Related Publications (1)
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.
PMID: 33906526BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Applied Bioenergetics Lab
Study Record Dates
First Submitted
March 21, 2022
First Posted
March 22, 2022
Study Start
September 1, 2021
Primary Completion
February 1, 2022
Study Completion
February 15, 2022
Last Updated
May 24, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share