Vitamin D Nasal Drops in Post COVID-19 Parosmia

NCT05269017 | Unknown Phase 2

• 1 other identifier: 1/2022 PHAR2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Parosmia

Keywords

Vitamin D; Olfactory dysfunction; Parosmia; Post COVID-19 Parosmia

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  After one month of treatment

Secondary Outcomes (1)

• Assessment of the side effects of Ivermectin nasal drops

  After one month of treatment

Study Arms (2)

Case group

EXPERIMENTAL

The case group patients will receive vitamin D3 nasal drops

Drug: Vitamin D3

Control group

ACTIVE COMPARATOR

The control group will remove local corticosteroid spray

Drug: Budesonide nasal spray

Interventions

Vitamin D3 DRUG

Devarol S amp containing 200,000 units per 2 ml giving a concentration of 5,000 units per drops for four weeks

Case group

Budesonide nasal spray DRUG

64 µg per puff in a dose of 1 puff for each nostril twice daily for four weeks

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia Faculty of Medicine

Shibīn al Kawm, Menoufia, 32511, Egypt

Location

Related Publications (9)

• 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.

  PMID: 32237238 BACKGROUND

• 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.

  PMID: 32564071 BACKGROUND

• 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.

  PMID: 34870334 BACKGROUND

• 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.

  PMID: 24529992 BACKGROUND

• 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.

  PMID: 25071589 BACKGROUND

• 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.

  PMID: 30661318 BACKGROUND

• 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.

  PMID: 27671249 BACKGROUND

• 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.

  PMID: 25330636 BACKGROUND

• 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.

  PMID: 32841423 BACKGROUND

MeSH Terms

Conditions

Olfaction Disorders

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Ahmad Hamdan, MD

CONTACT

00201008993175; Ahmed.Hamdan@med.menofia.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be blinded to the patient's group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 7, 2022
• Study Start: June 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication of the study results
• Access Criteria: On approval of the authors of the study

Locations

EG (1)