An interventional study of Vertistop D and Vertistop L in Benign Paroxysmal Positional Vertigo (BPPV), sponsored by Azienda Sanitaria Locale di Matera. Completed at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-04-22.
Sponsored by Azienda Sanitaria Locale di Matera · Not applicable, Interventional, and Prevention
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.
248 studies on the registry are indexed under Vertigo; 39 are open to participants now.
This study's enrollment of 128 is above the median of 57 across 186 interventional studies indexed under Vertigo.
Browse Vertigo studies →This is the only study on the registry with Azienda Sanitaria Locale di Matera as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Patients with normal vitamin D levels (\>30 ng/mL, \>75 nmol/L)
Dietary Supplement: Vertistop L
Patients meeting the inclusion criteria with normal levels of vitamin D (\>30 ng/mL, \>75 nmol/L)
Food supplement containing alpha-lipoic acid, carnosine, zinc, vitamin D3 and vitamins of group B, 1 tablet/day before meals
Food supplement containing alpha-lipoic acid, carnosine, zinc and curcumin, 2 tablets/day (morning and evening)
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
Time frame: 0, 6 months
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 0, 6 months
Incidence of adverse events
Time frame: 2, 4, 6 months
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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