drugset / Trial / NCT05269017
Vitamin D Nasal Drops in Post COVID-19 Parosmia
RandomizedParallel-groupSingle-blindTreatment
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
Timeline
- Start
- 2022-06
- Primary completion
- 2023-03
- Completion
- 2023-03
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Budesonide | Small molecule | 64 ug | Intranasal |
| Subject | Cholecalciferol | Other / unclassified | 20000 iu | Intranasal |
Indications
No indication recorded.