Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence
NCT ID: NCT05748249
Last Updated: 2023-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
126 participants
INTERVENTIONAL
2018-11-01
2019-09-30
Brief Summary
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The main purpose of the study is to evaluate, over a period of 6 months, the efficacy of Vertistop® D and Vertistop® L supplementation in preventing recurrences of BPPV (Benign Paroxysmal Positional Vertigo), in relation to blood levels of Vitamin D.
Detailed Description
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The determination of the Vitamin D concentration will be requested by the Investigating physician and the report will be evaluated during the randomisation visit (V1), Visit 2, (after 2 months from enrollment/start of treatment), Visit 3 (Follow-up visit up to 4 months from enrollment) and finally Visit 4 (Follow-up visit 6 months after enrollment).
The blood sample and the Vitamin D dosage will be carried out the week before the day of the visit agreed with the Investigator, in a trusted laboratory of the patient, provided that it has the legal authorizations and the analytical methodology satisfactory the measurement intervals reported in Protocol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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First arm Vertistop® L.
BPPV patients will be assigned to the first arm have a "sufficient" serum concentration of Vitamin D between 31 and 100 ng/mL (76 and 250 nmol/L), which will be treated with Vertistop® L.
Vertistop® D
Vitamin D supplementation
Second arm No Therapy
BPPV patients will be assigned to the second arm having serum concentrations of Vitamin D "Sufficient" between 31 and 100 ng/mL that will not be treated
No interventions assigned to this group
Third arm Vertistop® D
In the third arm, patients with serum values of Vitamin D "insufficient" i.e. between 20 and 30 ng/mL (50- 75 nmol/L) or "deficient" i.e. less than 20 ng/mL (50 nmol/L) which they will instead be treated with Vertistop® D.
Vertistop® D
Vitamin D supplementation
Interventions
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Vertistop® D
Vitamin D supplementation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who have BPPV of the posterior semicircular canal (SPC) geo and apo, lateral semicircular canal (SLC) geo and apo (single-canal, multi-canal).
3. Patients with relapsing BPPV, defined as two or more episodes in the past six months, or three or more episodes in the last 12 months.
4. Patients able to understand and follow the requirements of the Study Protocol and to provide their informed consent.
Exclusion Criteria
2. Secondary BPPV. Other causes of possible high recurrence BPPV and/or massive otolithic detachment:
* Migraine;
* Meniere's or delayed endolymphatic hydrops;
* Lindsay Hemenway syndrome;
* Otological and/or dental implant surgery in the last 3 months;
* Conclusion within 30 days.
3. Patients with Vitamin D values exceeding 100 ng/mL (\>250 nmol/L).
4. Pregnant or lactating women, as reported by the patient.
18 Years
85 Years
ALL
Yes
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Picciotti Pasqualina Maria
Principal Investigator
Principal Investigators
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Pasqualina M Picciotti
Role: PRINCIPAL_INVESTIGATOR
Università Cattolica del Sacro Cuore, Fondazione Policlinico Gemelli IRCCS
Locations
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Clinica Otorinolaringoiatrica
Roma, , Italy
Countries
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References
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Bhattacharyya N, Gubbels SP, Schwartz SR, Edlow JA, El-Kashlan H, Fife T, Holmberg JM, Mahoney K, Hollingsworth DB, Roberts R, Seidman MD, Steiner RW, Do BT, Voelker CC, Waguespack RW, Corrigan MD. Clinical Practice Guideline: Benign Paroxysmal Positional Vertigo (Update). Otolaryngol Head Neck Surg. 2017 Mar;156(3_suppl):S1-S47. doi: 10.1177/0194599816689667.
Imai T, Takeda N, Ikezono T, Shigeno K, Asai M, Watanabe Y, Suzuki M; Committee for Standards in Diagnosis of Japan Society for Equilibrium Research. Classification, diagnostic criteria and management of benign paroxysmal positional vertigo. Auris Nasus Larynx. 2017 Feb;44(1):1-6. doi: 10.1016/j.anl.2016.03.013. Epub 2016 May 9.
Epley JM. Positional vertigo related to semicircular canalithiasis. Otolaryngol Head Neck Surg. 1995 Jan;112(1):154-61. doi: 10.1016/S0194-59989570315-2.
von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, Neuhauser H. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):710-5. doi: 10.1136/jnnp.2006.100420. Epub 2006 Nov 29.
Eggers SDZ, Bisdorff A, von Brevern M, Zee DS, Kim JS, Perez-Fernandez N, Welgampola MS, Della Santina CC, Newman-Toker DE. Classification of vestibular signs and examination techniques: Nystagmus and nystagmus-like movements. J Vestib Res. 2019;29(2-3):57-87. doi: 10.3233/VES-190658.
Buki B, Ecker M, Junger H, Lundberg YW. Vitamin D deficiency and benign paroxysmal positioning vertigo. Med Hypotheses. 2013 Feb;80(2):201-4. doi: 10.1016/j.mehy.2012.11.029. Epub 2012 Dec 14.
Sheikhzadeh M, Lotfi Y, Mousavi A, Heidari B, Bakhshi E. The effect of serum vitamin D normalization in preventing recurrences of benign paroxysmal positional vertigo: A case-control study. Caspian J Intern Med. 2016 Summer;7(3):173-177.
Taneja MK, Taneja V. Vitamin d deficiency in e.N.T. Patients. Indian J Otolaryngol Head Neck Surg. 2013 Jan;65(1):57-60. doi: 10.1007/s12070-012-0603-9. Epub 2012 Dec 1.
Elmoursy MM, Abbas AS. The role of low levels of vitamin D as a co-factor in the relapse of benign paroxysmal positional vertigo (BPPV). Am J Otolaryngol. 2021 Nov-Dec;42(6):103134. doi: 10.1016/j.amjoto.2021.103134. Epub 2021 Jun 19.
Other Identifiers
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VERT-2017-001
Identifier Type: -
Identifier Source: org_study_id