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

Benign Paroxysmal Positional Vertigo (BPPV) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04849182
• Other study ID #: VERT-2017-001
• Status: Completed
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: November 3, 2020

Study information

• Verified date: April 2021
• Source: Azienda Sanitaria Locale di Matera
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: November 3, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• Benign Paroxysmal Positional Vertigo (BPPV)
• Dizziness
• Recurrence
• Vertigo

Intervention

Dietary Supplement:
• Vertistop D
Food supplement containing alpha-lipoic acid, carnosine, zinc, vitamin D3 and vitamins of group B, 1 tablet/day before meals
• Vertistop L
Food supplement containing alpha-lipoic acid, carnosine, zinc and curcumin, 2 tablets/day (morning and evening)

Locations

Country	Name	City	State
Italy	Policoro Hospital "Giovanni Paolo II"	Matera

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale di Matera

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events		2, 4, 6 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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