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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vertistop D | Active Comparator | Patients with deficiency (<20 ng/mL, <50 nmol/L) or insufficiency (20-30 ng/mL, 50-75 nmol/L) of Vitamin D |
|
| Vertistop L | Active Comparator | Patients with normal vitamin D levels (>30 ng/mL, >75 nmol/L) |
|
| Control group | No Intervention | Patients meeting the inclusion criteria with normal levels of vitamin D (>30 ng/mL, >75 nmol/L) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vertistop D | Dietary Supplement | Food supplement containing alpha-lipoic acid, carnosine, zinc, vitamin D3 and vitamins of group B, 1 tablet/day before meals |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 2, 4, 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policoro Hospital "Giovanni Paolo II" | Matera | 75100 | Italy |
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| ID | Term |
|---|---|
| D065635 | Benign Paroxysmal Positional Vertigo |
| ID | Term |
|---|---|
| D014717 | Vertigo |
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
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| Vertistop L | Dietary Supplement | Food supplement containing alpha-lipoic acid, carnosine, zinc and curcumin, 2 tablets/day (morning and evening) |
|
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 |
| D010038 |
| Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |