ParosmiaPhase 2NCT05269017
Vitamin D Nasal Drops in Post COVID-19 Parosmia
A Phase 2 study testing Vitamin D3 and Budesonide nasal spray in people with Parosmia, run by Menoufia University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parosmia
- What is being tested?
- Vitamin D3 and Budesonide nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2022to Mar 2023
- Phase
- Phase 2
- 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
None listed.
Who cannot join
- History of previous nasal surgery,
- Underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases),
- Hypersensitivity to vitamin D3.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Parosmia
- Being tested
- Vitamin D3, Budesonide nasal spray
- Keywords
- Vitamin D, Olfactory dysfunction, Parosmia, Post COVID-19 Parosmia
- Medical subject headings
- Olfaction Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Devarol S amp containing 200,000 units per 2 ml giving a concentration of 5,000 units per drops for four weeks
Budesonide nasal sprayDrug
64 µg per puff in a dose of 1 puff for each nostril twice daily for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | The case group patients will receive vitamin D3 nasal drops Receives: Drug: Vitamin D3 |
| Control group | Active comparator | The control group will remove local corticosteroid spray Receives: Drug: Budesonide nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between the pre and post treatment values
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.
Measured: After one month of treatment
Comparison between case and control groups regarding the post treatment results
Comparison between case and control groups regarding the post treatment results whether no improvement, partial improvement, or complete improvement
Measured: After one month of treatment
Secondary outcomes (1)
Assessment of the side effects of Ivermectin nasal drops
Assessment of the side effects of Ivermectin nasal drops among the case group
Measured: After one month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study startJun 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ParosmiaStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Mahmoud Hamdan, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269017
- Sponsor's protocol ID
- 1/2022 PHAR2
- Status last verified
- May 2022
- First submitted
- 4 Mar 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be available on request from the authors
Publications
Vaira LA, Salzano G, Deiana G, De Riu G. Anosmia and Ageusia: Common Findings in COVID-19 Patients. Laryngoscope. 2020 Jul;130(7):1787. doi: 10.1002/lary.28692. Epub 2020 Apr 15.
PubMed 32237238Parma V, Ohla K, Veldhuizen MG, Niv MY, Kelly CE, Bakke AJ, Cooper KW, Bouysset C, Pirastu N, Dibattista M, Kaur R, Liuzza MT, Pepino MY, Schopf V, Pereda-Loth V, Olsson SB, Gerkin RC, Rohlfs Dominguez P, Albayay J, Farruggia MC, Bhutani S, Fjaeldstad AW, Kumar R, Menini A, Bensafi M, Sandell M, Konstantinidis I, Di Pizio A, Genovese F, Ozturk L, Thomas-Danguin T, Frasnelli J, Boesveldt S, Saatci O, Saraiva LR, Lin C, Golebiowski J, Hwang LD, Ozdener MH, Guardia MD, Laudamiel C, Ritchie M, Havlicek J, Pierron D, Roura E, Navarro M, Nolden AA, Lim J, Whitcroft KL, Colquitt LR, Ferdenzi C, Brindha EV, Altundag A, Macchi A, Nunez-Parra A, Patel ZM, Fiorucci S, Philpott CM, Smith BC, Lundstrom JN, Mucignat C, Parker JK, van den Brink M, Schmuker M, Fischmeister FPS, Heinbockel T, Shields VDC, Faraji F, Santamaria E, Fredborg WEA, Morini G, Olofsson JK, Jalessi M, Karni N, D'Errico A, Alizadeh R, Pellegrino R, Meyer P, Huart C, Chen B, Soler GM, Alwashahi MK, Welge-Lussen A, Freiherr J, de Groot JHB, Klein H, Okamoto M, Singh PB, Hsieh JW; GCCR Group Author; Reed DR, Hummel T, Munger SD, Hayes JE. More Than Smell-COVID-19 Is Associated With Severe Impairment of Smell, Taste, and Chemesthesis. Chem Senses. 2020 Oct 9;45(7):609-622. doi: 10.1093/chemse/bjaa041.
PubMed 32564071Lerner DK, Garvey KL, Arrighi-Allisan AE, Filimonov A, Filip P, Shah J, Tweel B, Del Signore A, Schaberg M, Colley P, Govindaraj S, Iloreta AM. Clinical Features of Parosmia Associated With COVID-19 Infection. Laryngoscope. 2022 Mar;132(3):633-639. doi: 10.1002/lary.29982. Epub 2021 Dec 13.
PubMed 34870334Bikle DD. Vitamin D metabolism, mechanism of action, and clinical applications. Chem Biol. 2014 Mar 20;21(3):319-29. doi: 10.1016/j.chembiol.2013.12.016. Epub 2014 Feb 13.
PubMed 24529992Wobke TK, Sorg BL, Steinhilber D. Vitamin D in inflammatory diseases. Front Physiol. 2014 Jul 2;5:244. doi: 10.3389/fphys.2014.00244. eCollection 2014.
PubMed 25071589Cho SW, Zhang YL, Ko YK, Shin JM, Lee JH, Rhee CS, Kim DY. Intranasal Treatment With 1, 25-Dihydroxyvitamin D3 Alleviates Allergic Rhinitis Symptoms in a Mouse Model. Allergy Asthma Immunol Res. 2019 Mar;11(2):267-279. doi: 10.4168/aair.2019.11.2.267.
PubMed 30661318Enkhjargal B, McBride DW, Manaenko A, Reis C, Sakai Y, Tang J, Zhang JH. Intranasal administration of vitamin D attenuates blood-brain barrier disruption through endogenous upregulation of osteopontin and activation of CD44/P-gp glycosylation signaling after subarachnoid hemorrhage in rats. J Cereb Blood Flow Metab. 2017 Jul;37(7):2555-2566. doi: 10.1177/0271678X16671147. Epub 2016 Jan 1.
PubMed 27671249Gong W, Feng Y, Yan P, Li S, Yu C, Zhou X, Xu F, Zhang D, Ren X, Zhou J, Jiang Y. [Effect of nasal instillation of vitamin D3 on patient with allergic rhinitis symptoms]. Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2014 Jul;28(14):1031-3. Chinese.
PubMed 25330636Shin YH, Ha EK, Kim JH, Yon DK, Lee SW, Sim HJ, Sung M, Jee HM, Han MY. Serum vitamin D level is associated with smell dysfunction independently of aeroallergen sensitization, nasal obstruction, and the presence of allergic rhinitis in children. Pediatr Allergy Immunol. 2021 Jan;32(1):116-123. doi: 10.1111/pai.13341. Epub 2020 Oct 8.
PubMed 32841423
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Therapeutic Effect of Vitamin D Nasal Drops in the Treatment of Post COVID-19 Parosmia
- ClinicalTrials.gov ID
- NCT05269017
- Acronym / sponsor ID
- 1/2022 PHAR2
- Conditions
- Parosmia
- Keywords
- Vitamin D, Olfactory dysfunction, Parosmia, Post COVID-19 Parosmia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 7 Mar 2022 (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 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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Drug: Vitamin D3The case group patients will receive vitamin D3 nasal drops |
| Control group | Active comparator | Drug: Budesonide nasal sprayThe control group will remove local corticosteroid spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- History of previous nasal surgery,
- Underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases),
- Hypersensitivity to vitamin D3.
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 |
|---|---|---|
| Vitamin D3Devarol S amp containing 200,000 units per 2 ml giving a concentration of 5,000 units per drops for four weeks | Drug | Case group |
| Budesonide nasal spray64 µg per puff in a dose of 1 puff for each nostril twice daily for four weeks | Drug | Control group |
Primary outcome
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.
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
1 secondary outcome
Assessment of the side effects of Ivermectin nasal drops
Time frame: After one month of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Background: PubMed 32237238Vaira LA, Salzano G, Deiana G, De Riu G. Anosmia and Ageusia: Common Findings in COVID-19 Patients. Laryngoscope. 2020 Jul;130(7):1787. doi: 10.1002/lary.28692. Epub 2020 Apr 15.
- Background: PubMed 32564071Parma V, Ohla K, Veldhuizen MG, Niv MY, Kelly CE, Bakke AJ, Cooper KW, Bouysset C, Pirastu N, Dibattista M, Kaur R, Liuzza MT, Pepino MY, Schopf V, Pereda-Loth V, Olsson SB, Gerkin RC, Rohlfs Dominguez P, Albayay J, Farruggia MC, Bhutani S, Fjaeldstad AW, Kumar R, Menini A, Bensafi M, Sandell M, Konstantinidis I, Di Pizio A, Genovese F, Ozturk L, Thomas-Danguin T, Frasnelli J, Boesveldt S, Saatci O, Saraiva LR, Lin C, Golebiowski J, Hwang LD, Ozdener MH, Guardia MD, Laudamiel C, Ritchie M, Havlicek J, Pierron D, Roura E, Navarro M, Nolden AA, Lim J, Whitcroft KL, Colquitt LR, Ferdenzi C, Brindha EV, Altundag A, Macchi A, Nunez-Parra A, Patel ZM, Fiorucci S, Philpott CM, Smith BC, Lundstrom JN, Mucignat C, Parker JK, van den Brink M, Schmuker M, Fischmeister FPS, Heinbockel T, Shields VDC, Faraji F, Santamaria E, Fredborg WEA, Morini G, Olofsson JK, Jalessi M, Karni N, D'Errico A, Alizadeh R, Pellegrino R, Meyer P, Huart C, Chen B, Soler GM, Alwashahi MK, Welge-Lussen A, Freiherr J, de Groot JHB, Klein H, Okamoto M, Singh PB, Hsieh JW; GCCR Group Author; Reed DR, Hummel T, Munger SD, Hayes JE. More Than Smell-COVID-19 Is Associated With Severe Impairment of Smell, Taste, and Chemesthesis. Chem Senses. 2020 Oct 9;45(7):609-622. doi: 10.1093/chemse/bjaa041.
- Background: PubMed 34870334Lerner DK, Garvey KL, Arrighi-Allisan AE, Filimonov A, Filip P, Shah J, Tweel B, Del Signore A, Schaberg M, Colley P, Govindaraj S, Iloreta AM. Clinical Features of Parosmia Associated With COVID-19 Infection. Laryngoscope. 2022 Mar;132(3):633-639. doi: 10.1002/lary.29982. Epub 2021 Dec 13.
- Background: PubMed 24529992Bikle DD. Vitamin D metabolism, mechanism of action, and clinical applications. Chem Biol. 2014 Mar 20;21(3):319-29. doi: 10.1016/j.chembiol.2013.12.016. Epub 2014 Feb 13.
- Background: PubMed 25071589Wobke TK, Sorg BL, Steinhilber D. Vitamin D in inflammatory diseases. Front Physiol. 2014 Jul 2;5:244. doi: 10.3389/fphys.2014.00244. eCollection 2014.
- Background: PubMed 30661318Cho SW, Zhang YL, Ko YK, Shin JM, Lee JH, Rhee CS, Kim DY. Intranasal Treatment With 1, 25-Dihydroxyvitamin D3 Alleviates Allergic Rhinitis Symptoms in a Mouse Model. Allergy Asthma Immunol Res. 2019 Mar;11(2):267-279. doi: 10.4168/aair.2019.11.2.267.
- Background: PubMed 27671249Enkhjargal B, McBride DW, Manaenko A, Reis C, Sakai Y, Tang J, Zhang JH. Intranasal administration of vitamin D attenuates blood-brain barrier disruption through endogenous upregulation of osteopontin and activation of CD44/P-gp glycosylation signaling after subarachnoid hemorrhage in rats. J Cereb Blood Flow Metab. 2017 Jul;37(7):2555-2566. doi: 10.1177/0271678X16671147. Epub 2016 Jan 1.
- Background: PubMed 25330636Gong W, Feng Y, Yan P, Li S, Yu C, Zhou X, Xu F, Zhang D, Ren X, Zhou J, Jiang Y. [Effect of nasal instillation of vitamin D3 on patient with allergic rhinitis symptoms]. Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2014 Jul;28(14):1031-3. Chinese.
- Background: PubMed 32841423Shin YH, Ha EK, Kim JH, Yon DK, Lee SW, Sim HJ, Sung M, Jee HM, Han MY. Serum vitamin D level is associated with smell dysfunction independently of aeroallergen sensitization, nasal obstruction, and the presence of allergic rhinitis in children. Pediatr Allergy Immunol. 2021 Jan;32(1):116-123. doi: 10.1111/pai.13341. Epub 2020 Oct 8.
- Individual participant dataSharing planned: Yes. Study data will be available on request from the authors
Related trials for Parosmia
RecruitingObservational study
Longitudinal Deep Phenotyping of Central Mechanisms in Dysosmia: A Pilot Study Using Electrobulbogram (EBG), Functional MRI (fMRI), and Diffusion-Weighted Imaging (DWI)
Respiratory Tract Infection, Smell Disorder
Not yet recruitingObservational study
Neural Dissimilarity in Patients With Chronic Rhinosinusitis With Nasal Polyps Treated With Biologics
Olfactory Dysfunction, Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Recruiting
Olfactory Training as a Treatment for Olfactory Dysfunction Post COVID-19
Hyposmia, COVID-19
RecruitingPhase 2/3
Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT for Long COVID)
Smell Dysfunction, Olfactory Disorder
Recruiting
Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia
Paraosmia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 and Budesonide nasal spray in people with Parosmia, run by Menoufia University at 1 site in Egypt.
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 0 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: status not confirmed, as of the sponsor's last update on 11 May 2022. 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 Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmad Hamdan, MD (00201008993175, Ahmed.Hamdan@med.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between the pre and post treatment values (time frame: After one month of treatment). The study lists 2 primary outcomes in all. 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 NCT05269017, which also lists 9 linked publications.
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 11 May 2022.