Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence
Benign Paroxysmal Positional Vertigo, Vitamin D, Antioxidants
About this trial
This is an interventional prevention trial for Benign Paroxysmal Positional Vertigo
Eligibility Criteria
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.
Sites / Locations
- Clinica Otorinolaringoiatrica
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
No Intervention
Experimental
First arm Vertistop® L.
Second arm No Therapy
Third arm Vertistop® D
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.
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
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.