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

NCT ID: NCT05290298

Last Updated: 2022-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-02-15

Brief Summary

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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

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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)

Group Type EXPERIMENTAL

NITRATE

Intervention Type DIETARY_SUPPLEMENT

Multi-component nutritional formula

PLACEBO

Placebo (2.5 grams of inulin)

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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NITRATE

Multi-component nutritional formula

Intervention Type DIETARY_SUPPLEMENT

PLACEBO

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Novi Sad, Faculty of Sport and Physical Education

OTHER

Sponsor Role lead

Responsible Party

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Sergej Ostojic

Head of Applied Bioenergetics Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, Serbia

Site Status

Countries

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Serbia

References

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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.

Reference Type BACKGROUND
PMID: 33906526 (View on PubMed)

Other Identifiers

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02-TLI/2021-2

Identifier Type: -

Identifier Source: org_study_id

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