The Effect of Novel D3 Use as a Mouthwash in COVID-19 Patients

The PI's goal of this [interventional/clinical trial] is to [explore the antiviral properties of vitamin D3 on saliva samples collected before and after the use of a vitamin D3 mouthwash] in [ adult participants, both genders, with COVID-19 who tested positive on a swab test]. The main question[s] aims to answer [is]:

[Assess the antiviral potential of a novel vitamin D-based mouthwash in COVID-19-positive participants].

PI will compare both [Control group: saliva only- before use of mouthwash], and the [study group: after use of the mouthwash in saliva] to see if there is [any veridical effect present in saliva after running lab tests].

Participants will [self-collect saliva in a given tube (color coded orange), then 10-15 minutes later or more, participants will swish with D3 mouthwash, and will give another sample [saliva + mouthwash] in another (green labeled tube). For each participant, each of the following will be given:

* 2 collecting tubes: orange labeled tube (for saliva collection only) and green labeled tube (for saliva collection after mouthwash use). * The vial containing vitamin D3 mouthwash.

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Key information

Conditions

Corona Virus Disease 19 (COVID-19) COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

KingFaisal

Jeddah, Saudi Arabia

About this study

Twenty-five adult participants confirmed COVID-19-positive, via rapid antigen testing (RAT) thru nasal swabs (NS), followed by saliva samples collected before and after using a vitamin D3 mouthwash. Samples were analyzed using RAT and rapid polymerase chain reaction (R-PCR) to measure viral load.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult participants confirmed positive for COVID-19 by RAT.
Participants at the King Faisal Specialist Hospital & Research Center in Jeddah (KFSHRC, J) outpatient departments (OPD) and/or department of emergency medicine (DEM).

Exclusion criteria

Immunocompromised and/or pregnant participants.
Pediatric participants and patients aged <18 years.
Participants on a high-dose vitamin D prescription (i.e., 10, 000 IU or more).

Treatment and study plan

Cholecalciferol (vitaminD3)

Drug

Vitamin D3 mouthwash was prepared for COVID-19 participants, to compare between the saliva only (control group), and with the use of mouthwash in saliva after the participants swish for 60 seconds (experimental group) and compare the effect of vitamin D over the virus in saliva, from both groups by testing via RAT and R-PCR.

Primary outcomes

No effect of D3 mouthwash on saliva of COVID-19 patients

Time frame: 30-60 minutes was the time frame for each participant, during same day of COVID-19 testing.

Post-rinse, RAT positivity dropped by 68%, likely due to physical dilution rather than antiviral action. R-PCR showed no significant reduction in viral RNA; in some cases, a slight increase was observed, potentially reflecting a cellular response to D3

Sponsors and collaborators

Lead sponsor

King Faisal Specialist Hospital & Research Center

Other

Registry information

Official study title

Vitamin D3, Mouthwash, Saliva Testing, Covid-19, Antiviral Testing

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 16, 2025
Registry last updated: Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed