Vitamin D Nasal Drops in Post COVID-19 Parosmia

May 5, 2022 updated by: Ahmad Mahmoud Hamdan, Menoufia University

The Potential Therapeutic Effect of Vitamin D Nasal Drops in the Treatment of Post COVID-19 Parosmia

The current study will be a pilot study for a randomized controlled trial conducted on patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine To evaluate the effect of vitamin D nasal drops in the treatment of post COVID 19 parosmia

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The current study will be a pilot study for a randomized controlled trial conducted on 60 patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine after approval of the institutional review board and taking informed written consent from every patient before participation in the study.

To be included in the study, patients should be more than 18 years old, have a history of COVID 19 infection more than three months ago as confirmed by PCR test, have a post COVID parosmia, and have no history of systemic steroid administration over the last one month. History of previous nasal surgery, underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases), and hypersensitivity to Ivermectin were the exclusion criteria for this study.

Patients of the study will be randomly and equally distributed between case and control groups using block randomization methods using 4 blocks each comprising 4 patients with 6 patterns for every block one of which was selected randomly using random numbers generated by Excel program. The case group will receive a 4 week course using Devarol S amp containing 200,000 units per 2 ml giving a concentration of 5,000 units per drop. The patients will receive two drops per nostril twice daily. The Control group will receive a 4 weeks course of local steroids in the form of budesonide (64 µg per puff in a dose of 1 puff for each nostril twice daily.

Assessment protocol:

Patients of the study will be assessed before and at the end of the treatment protocol with history taking to define the inclusion and exclusion criteria. Endoscopic examination of the nasal cavity will be performed to exclude any other intranasal pathology. The degree of parosmia will be assessed using a visual analog scale before and four weeks after treatment.

Outcome measures:

Primary outcome measures will include a comparison between the pre and post treatment values of visual analog scales of parosmia, and a comparison between case and control groups regarding the post treatment results whether no improvement, partial improvement, or complete improvement. Secondary outcome measures will include assessment of the side effects of Ivermectin nasal drops among the case group.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Menoufia
      • Shibīn Al Kawm, Menoufia, Egypt, 32511
        • Menoufia Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

nclusion Criteria:

  • Patients should be more than 18 years old,
  • Patients having a history of COVID 19 infection more than three months ago as confirmed by PCR test,
  • Patients having a post COVID parosmia,
  • Patients having no history of systemic steroid administration over the last one month.

Exclusion Criteria:

  • History of previous nasal surgery,
  • Underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases),
  • Hypersensitivity to vitamin D3.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Case group
The case group patients will receive vitamin D3 nasal drops
Drug: Vitamin D3
Devarol S amp containing 200,000 units per 2 ml giving a concentration of 5,000 units per drops for four weeks
Active Comparator: Control group
The control group will remove local corticosteroid spray
Drug: Budesonide nasal spray
64 µg per puff in a dose of 1 puff for each nostril twice daily for four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between the pre and post treatment values
Time Frame: After one month of treatment
Comparison between the pre and post-treatment values of visual analog scale values for post-COVD-19 parosmia. The values range from 0 to 10 with 10 indicating severe parosmia.
After one month of treatment
Comparison between case and control groups regarding the post treatment results
Time Frame: After one month of treatment
Comparison between case and control groups regarding the post treatment results whether no improvement, partial improvement, or complete improvement
After one month of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the side effects of Ivermectin nasal drops
Time Frame: After one month of treatment
Assessment of the side effects of Ivermectin nasal drops among the case group
After one month of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 4, 2022

First Posted (Actual)

March 7, 2022

Study Record Updates

Last Update Posted (Actual)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2022 PHAR2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Study data will be available on request from the authors

IPD Sharing Time Frame

After publication of the study results

IPD Sharing Access Criteria

On approval of the authors of the study

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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