Corona Virus Disease 19 (COVID-19)
Conditions
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.
Interventions
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.
Sponsors
King Faisal Specialist Hospital & Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Saudi Arabia
Outcome results
None listed