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

• ClinicalTrials.gov Identifier: NCT04849182
• Recruitment Status: Completed
• First Posted: April 19, 2021
• Last Update Posted: April 22, 2021
• Sponsor: Azienda Sanitaria Locale di Matera
• Information provided by (Responsible Party): Prof. Giacinto Asprella Libonati, Azienda Sanitaria Locale di Matera

Study Description

Brief 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)

Condition or disease	Intervention/treatment	Phase
Benign Paroxysmal Positional Vertigo (BPPV)	Dietary Supplement: Vertistop D; Dietary Supplement: Vertistop L	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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)
• Actual Study Start Date: December 4, 2018
• Actual Primary Completion Date: June 30, 2020
• Actual Study Completion Date: November 3, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Number of BPPV recurrences in patients supplemented with Vertistop D [ Time Frame: 0, 6 months ]
   Change in the number of BPPV recurrences associated with the increase or normalization of Vitamin D serum levels after supplementation with Vertistop D

Secondary Outcome Measures :

1. Number of BPPV recurrences in patients supplemented with Vertistop-L [ Time Frame: 0, 6 months ]
   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)
2. Mean difference in Dizziness Handicap Inventory (DHI) values [ Time Frame: 0, 6 months ]
   This parameter is defined as the mean difference in the DHI values between the baseline visit and the final visit (after 6 months)
3. Mean difference in the Visual Numeric Scale (VNS) values [ Time Frame: 0, 6 months ]
   This parameter is defined as the mean difference in the VNS values between the baseline visit and the final visit (after 6 months)
4. Mean difference in the Visual Analogue Scale (VAS) values [ Time Frame: 0, 6 months ]
   This parameter is defined as the mean difference in the VAS values between the baseline visit and the final visit (after 6 months)

Other Outcome Measures:

1. Incidence of adverse events [ Time Frame: 2, 4, 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Italy

Policoro Hospital "Giovanni Paolo II"

Matera, Italy, 75100

Sponsors and Collaborators

Azienda Sanitaria Locale di Matera

More Information

• Responsible Party: Prof. Giacinto Asprella Libonati, Medical Executive, Azienda Sanitaria Locale di Matera
• ClinicalTrials.gov Identifier: NCT04849182
• Other Study ID Numbers: VERT-2017-001
• First Posted: April 19, 2021
• Last Update Posted: April 22, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Giacinto Asprella Libonati, Azienda Sanitaria Locale di Matera:

BPPV; Vertistop; Vitamin D; Alpha-lipoic acid; Zinc

Additional relevant MeSH terms:

Vertigo; Benign Paroxysmal Positional Vertigo; Recurrence; Dizziness; Disease Attributes; Pathologic Processes; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Sensation Disorders