search
Back to results

Vitamin D Nasal Drops in Post COVID-19 Parosmia

Primary Purpose

Parosmia

Status
Not yet recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D3
Budesonide nasal spray
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parosmia focused on measuring Vitamin D, Olfactory dysfunction, Parosmia, Post COVID-19 Parosmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Menoufia Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Case group

Control group

Arm Description

The case group patients will receive vitamin D3 nasal drops

The control group will remove local corticosteroid spray

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Assessment of the side effects of Ivermectin nasal drops
Assessment of the side effects of Ivermectin nasal drops among the case group

Full Information

First Posted
March 4, 2022
Last Updated
May 5, 2022
Sponsor
Menoufia University
search

1. Study Identification

Unique Protocol Identification Number
NCT05269017
Brief Title
Vitamin D Nasal Drops in Post COVID-19 Parosmia
Official Title
The Potential Therapeutic Effect of Vitamin D Nasal Drops in the Treatment of Post COVID-19 Parosmia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parosmia
Keywords
Vitamin D, Olfactory dysfunction, Parosmia, Post COVID-19 Parosmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The statistician will be blinded to the patient's group
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Case group
Arm Type
Experimental
Arm Description
The case group patients will receive vitamin D3 nasal drops
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The control group will remove local corticosteroid spray
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Intervention Description
Devarol S amp containing 200,000 units per 2 ml giving a concentration of 5,000 units per drops for four weeks
Intervention Type
Drug
Intervention Name(s)
Budesonide nasal spray
Intervention Description
64 µg per puff in a dose of 1 puff for each nostril twice daily for four weeks
Primary Outcome Measure Information:
Title
Comparison between the pre and post treatment values
Description
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.
Time Frame
After one month of treatment
Title
Comparison between case and control groups regarding the post treatment results
Description
Comparison between case and control groups regarding the post treatment results whether no improvement, partial improvement, or complete improvement
Time Frame
After one month of treatment
Secondary Outcome Measure Information:
Title
Assessment of the side effects of Ivermectin nasal drops
Description
Assessment of the side effects of Ivermectin nasal drops among the case group
Time Frame
After one month of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Hamdan, MD
Phone
00201008993175
Email
Ahmed.Hamdan@med.menofia.edu.eg
Facility Information:
Facility Name
Menoufia Faculty of Medicine
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
32511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
32237238
Citation
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.
Results Reference
background
PubMed Identifier
32564071
Citation
Parma 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. Erratum In: Chem Senses. 2021 Jan 1;46:
Results Reference
background
PubMed Identifier
34870334
Citation
Lerner 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.
Results Reference
background
PubMed Identifier
24529992
Citation
Bikle 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.
Results Reference
background
PubMed Identifier
25071589
Citation
Wobke 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.
Results Reference
background
PubMed Identifier
30661318
Citation
Cho 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.
Results Reference
background
PubMed Identifier
27671249
Citation
Enkhjargal 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.
Results Reference
background
PubMed Identifier
25330636
Citation
Gong 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.
Results Reference
background
PubMed Identifier
32841423
Citation
Shin 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.
Results Reference
background

Learn more about this trial

Vitamin D Nasal Drops in Post COVID-19 Parosmia

We'll reach out to this number within 24 hrs