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

Overview

The study involves the evaluation of 3 groups of subjects (3-arm study). Patients diagnosed with BPPV and "sufficient" serum concentrations of Vitamin D (\>30 ng/mL, \>75 nmol/L) at baseline may be treated with 2 tablets per day (morning and evening) of Vertistop® L ( Alpha-lipoic acid, carnosine, zinc and curcumin) or untreated, on the basis of the randomization criterion to which they will be assigned. Patients with Vitamin D "deficiency" (\<20 ng/mL, \<50 nmol/L) or Vitamin D "insufficient" (20-30 ng/mL, 50-75 nmol/L) at baseline, or subsequent follow-up, they will be treated for 2 months with Vertistop® D (alpha-lipoic acid, carnosine and zinc, vitamin D3 and vitamins of the B complex) taking 1 tablet a day (before meals). 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.

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.