Nitrate-based Nutritional Formula for Oxygen Saturation a... | NCT05290298

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

NCT05290298

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Status

Completed

Last Update Posted

May 24, 2022Actual

Enrollment

52Actual

Phase

Not Applicable

Conditions

COVID-19

Interventions

NITRATE
PLACEBO

Countries

Serbia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Feb 1, 2022Actual

Completion Date

Feb 15, 2022Actual

First Submitted Date

Mar 21, 2022

First Submission Date that Met QC Criteria

Mar 21, 2022

First Posted Date

Mar 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2022

Last Update Posted Date

May 24, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sergej Ostojic, Head of Applied Bioenergetics Lab, University of Novi Sad, Faculty of Sport and Physical EducationPrincipal Investigator

Lead Sponsor

University of Novi Sad, Faculty of Sport and Physical EducationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NITRATE	Experimental	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
PLACEBO	Placebo Comparator	Placebo (2.5 grams of inulin)	Dietary Supplement: PLACEBO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NITRATE	Dietary Supplement	Multi-component nutritional formula	NITRATE

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Applied Bioenergetics Lab at Faculty of Sport and PE		Novi Sad	Vojvodina	21000	Serbia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33906526	Background	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.

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

ID	Term
D000838	Anions
D007477	Ions
D004573	Electrolytes
D007287	Inorganic Chemicals
D017942