Corona Virus Disease 19 (COVID-19)Phase 1NCT07068282
The Effect of Novel D3 Use as a Mouthwash in COVID-19 Patients
A Phase 1 study testing Cholecalciferol (vitaminD3) in people with Corona Virus Disease 19 (COVID-19), run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Disease 19 (COVID-19)
- What is being tested?
- Cholecalciferol (vitaminD3)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 24 Jul 2024to 12 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D3, Mouthwash, Saliva Testing, Covid-19, Antiviral Testing
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].
Read more
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.
Read the 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.
- Conditions
- Corona Virus Disease 19 (COVID-19)
- Being tested
- Cholecalciferol (vitaminD3)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| D3 mouthwash in COVID-19 saliva | Experimental | Not described Receives: Drug: Cholecalciferol (vitaminD3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30-60 minutes was the time frame for each participant, during same day of COVID-19 testing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start24 Jul 2024
- Primary completion25 Jan 2025
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corona Virus Disease 19 (COVID-19)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Feteih, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068282
- Sponsor's protocol ID
- 2022-32
- Status last verified
- Jan 2024
- First submitted
- 24 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feteih SMN, Heaphy ELG, Aljagthmi A, Abumdaini A, Bayumi D, Albishi G, Dada A. Vitamin D3 oral rinsing reduces salivary SARS-CoV-2 antigen detectability: a clinical trial with public health implications. Front Oral Health. 2026 Sep 1;7:1943222. doi: 10.3389/froh.2026.1943222. eCollection 2026.
PubMed 42745778
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D3, Mouthwash, Saliva Testing, Covid-19, Antiviral Testing
- ClinicalTrials.gov ID
- NCT07068282
- Acronym / sponsor ID
- 2022-32
- Conditions
- Corona Virus Disease 19 (COVID-19)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D3 mouthwash in COVID-19 saliva | Experimental | Drug: Cholecalciferol (vitaminD3) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholecalciferol (vitaminD3)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. | Drug | D3 mouthwash in COVID-19 saliva |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Derived from this study: PubMed 42745778Feteih SMN, Heaphy ELG, Aljagthmi A, Abumdaini A, Bayumi D, Albishi G, Dada A. Vitamin D3 oral rinsing reduces salivary SARS-CoV-2 antigen detectability: a clinical trial with public health implications. Front Oral Health. 2026 Sep 1;7:1943222. doi: 10.3389/froh.2026.1943222. eCollection 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cholecalciferol (vitaminD3) in people with Corona Virus Disease 19 (COVID-19), run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07068282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.