Benign Paroxysmal Positional Vertigo (BPPV)
Conditions
Keywords
BPPV, Vertistop, Vitamin D, Alpha-lipoic acid, Zinc
Brief summary
Randomized, 3-arm controlled clinical study, to evaluate the effectiveness of supplementation with Vertistop® D (food supplement containing alpha-lipoic acid at modified release, Carnosine and Zinc, Vitamin D and Vitamins B) and Vertistop® L (food supplement containing fast releasing alpha-lipoic acid, Carnosine, Zinc and Curcumin) in preventing recurrence of high-recurrence BPPV (Benign Paroxysmal Positional Vertigo)
Detailed description
Benign paroxysmal positional vertigo (BPPV) is the most common type of vertigo detectable in otoneurological clinical practice. It is characterized by violent, short and relapsing vertiginous crises that arise when the patient assumes certain positions of the head in the space and is accompanied by a usually typical paroxysmal positional nystagmus. In most cases we cannot trace the exact causal agent, so we mainly identify two forms: primitive forms and secondary forms. BPPV therapy is essentially physical, and it is based on specific maneuvers which make the otoconial mass come out of the semicircular canal. Recent studies showed the existence of a seasonal trend of BPPV related to fluctuations in Vitamin D levels. Based on these considerations this clinical trial was designed in order to evaluate the possible efficacy of the administration of Vitamin D (Vertistop® D) in preventing recurrence of BPPV.
Interventions
DIETARY_SUPPLEMENTVertistop D
Food supplement containing alpha-lipoic acid, carnosine, zinc, vitamin D3 and vitamins of group B, 1 tablet/day before meals
DIETARY_SUPPLEMENTVertistop L
Food supplement containing alpha-lipoic acid, carnosine, zinc and curcumin, 2 tablets/day (morning and evening)
Sponsors
Azienda Sanitaria Locale di Matera
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary BPPV; * Patients having BPPV of CSP or CSL (geo or apo, single or multi channel); * Patients with recurrent BPPV, defined as two or more episodes over the last six months, or three or more episodes in the last 12 months; * Informed consent.
Exclusion criteria
* Patients under 18 years of age; * Secondary BPPV; * Vitamin D levels greater than 100 ng/mL (\>250 nmol/L); * Pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of BPPV recurrences in patients supplemented with Vertistop D | 0, 6 months | Change in the number of BPPV recurrences associated with the increase or normalization of Vitamin D serum levels after supplementation with Vertistop D |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of BPPV recurrences in patients supplemented with Vertistop-L | 0, 6 months | This parameter is defined as the difference in the number of BPPV recurrences observed in the period between the baseline visit and the final visit (after 6 months) |
| Mean difference in Dizziness Handicap Inventory (DHI) values | 0, 6 months | This parameter is defined as the mean difference in the DHI values between the baseline visit and the final visit (after 6 months) |
| Mean difference in the Visual Numeric Scale (VNS) values | 0, 6 months | This parameter is defined as the mean difference in the VNS values between the baseline visit and the final visit (after 6 months) |
| Mean difference in the Visual Analogue Scale (VAS) values | 0, 6 months | This parameter is defined as the mean difference in the VAS values between the baseline visit and the final visit (after 6 months) |
Other
| Measure | Time frame |
|---|---|
| Incidence of adverse events | 2, 4, 6 months |
Countries
Italy
Outcome results
None listed