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

NCT07068282 | Completed Phase 1 DMC

• 1 other identifier: 2022-32
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Corona Virus Disease 19 (COVID-19)

Outcome Measures

Primary Outcomes (1)

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

  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

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

Study Arms (1)

D3 mouthwash in COVID-19 saliva

EXPERIMENTAL

Drug: Cholecalciferol (vitaminD3)

Interventions

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.

D3 mouthwash in COVID-19 saliva

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

KingFaisal

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Periodontist

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 16, 2025
• Study Start: July 24, 2024
• Primary Completion: January 25, 2025
• Study Completion: February 12, 2025
• Last Updated: July 16, 2025

Record last verified: 2024-01

Locations

SA (1)