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

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)

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)

Study Overview

• Status: Completed
• Conditions: Benign Paroxysmal Positional Vertigo (BPPV)
• Intervention / Treatment: Dietary supplement: Vertistop D; Dietary supplement: Vertistop L

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Matera, Italy, 75100
    • Policoro Hospital "Giovanni Paolo II"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	2, 4, 6 months

Collaborators and Investigators

• Sponsor: Azienda Sanitaria Locale di Matera

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): November 3, 2020

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Vitamin D; Zinc; BPPV; Vertistop; Alpha-lipoic acid
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Recurrence; Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
• Other Study ID Numbers: VERT-2017-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No