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

NCT ID: NCT07068282

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-24
• Study Completion Date: 2025-02-12

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.

Conditions

Corona Virus Disease 19 (COVID-19)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

D3 mouthwash in COVID-19 saliva

Group Type: EXPERIMENTAL

Cholecalciferol (vitaminD3)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role: lead

Responsible Party

Sarah Feteih

Consultant, Periodontist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KingFaisal

Jeddah, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

2022-32

Identifier Type: -

Identifier Source: org_study_id