Vertistop® D and Vertistop® L in Preventing Recurrence of High-recurrence BPPV

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized, 3-arm Controlled Clinical Trial, Designed to Evaluate the Effectiveness of Supplementation With Vertistop® D and Vertistop® L in Preventing Recurrence of High-recurrence BPPV (Benign Paroxysmal Positional Vertigo)

Conditions
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Benign Paroxysmal Positional Vertigo (BPPV)

Intervention / Treatment
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* Dietary Supplement: Vertistop D
* Dietary Supplement: Vertistop L


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vertistop D<br>Patients with deficiency (<20 ng/mL, <50 nmol/L) or insufficiency (20-30 ng/mL, 50-75 nmol/L) of Vitamin D | Dietary Supplement: Vertistop D<br>* Food supplement containing alpha-lipoic acid, carnosine, zinc, vitamin D3 and vitamins of group B, 1 tablet/day before meals<br>|
| Active Comparator: Vertistop L<br>Patients with normal vitamin D levels (>30 ng/mL, >75 nmol/L) | Dietary Supplement: Vertistop L<br>* Food supplement containing alpha-lipoic acid, carnosine, zinc and curcumin, 2 tablets/day (morning and evening)<br>|
| No Intervention: Control group<br>Patients meeting the inclusion criteria with normal levels of vitamin D (>30 ng/mL, >75 nmol/L) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of BPPV recurrences in patients supplemented with Vertistop D | Change in the number of BPPV recurrences associated with the increase or normalization of Vitamin D serum levels after supplementation with Vertistop D | 0, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of BPPV recurrences in patients supplemented with Vertistop-L | 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) | 0, 6 months | 
| Mean difference in Dizziness Handicap Inventory (DHI) values | This parameter is defined as the mean difference in the DHI values between the baseline visit and the final visit (after 6 months) | 0, 6 months | 
| Mean difference in the Visual Numeric Scale (VNS) values | This parameter is defined as the mean difference in the VNS values between the baseline visit and the final visit (after 6 months) | 0, 6 months | 
| Mean difference in the Visual Analogue Scale (VAS) values | This parameter is defined as the mean difference in the VAS values between the baseline visit and the final visit (after 6 months) | 0, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPPV, Vertistop, Vitamin D, Alpha-lipoic acid, Zinc