Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence

Patients will be assigned to one of the three study groups following a randomization list with reference to groups 1 and 2 and according to the serum concentrations of 25(OH) Vitamin D, evaluated at the baseline visit, with reference to group 3.

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.

Inclusion criteria

• Patients of both sexes, aged between 18 and 85 years, diagnosed with primary BPPV.
• Patients who have BPPV of the posterior semicircular canal (SPC) geo and apo, lateral semicircular canal (SLC) geo and apo (single-canal, multi-canal).
• 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.
• Patients able to understand and follow the requirements of the Study Protocol and to provide their informed consent.

Exclusion criteria

• Patients under the age of 18.
• 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.
• Patients with Vitamin D values exceeding 100 ng/mL (>250 nmol/L).
• Pregnant or lactating women, as reported by the patient.