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

Not Applicable

Completed

• Conditions: Corona Virus Disease 19 (COVID-19)
• Interventions: Drug: Cholecalciferol (vitaminD3)

• Registration Number: NCT07068282
• Lead Sponsor: King Faisal Specialist Hospital & Research Center

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-07-24
• Primary Completion: 2025-01-25
• Study Completion: 2025-02-12
• Study First Submitted: 2025-06-24
• Study First Submitted QC: 2025-07-06
• Last Update Submitted: 2025-07-06
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
D3 mouthwash in COVID-19 saliva	Cholecalciferol (vitaminD3)	-

Primary Outcome Measures

Name	Time	Method
No effect of D3 mouthwash on saliva of COVID-19 patients	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

Trial Locations

Locations (1)

KingFaisal; 🇸🇦 Jeddah, Saudi Arabia