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

NCT ID: NCT04849182

Last Updated: 2021-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-04
• Study Completion Date: 2020-11-03

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)

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.

Conditions

Benign Paroxysmal Positional Vertigo (BPPV)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vertistop D

Patients with deficiency (\<20 ng/mL, \<50 nmol/L) or insufficiency (20-30 ng/mL, 50-75 nmol/L) of Vitamin D

Group Type: ACTIVE_COMPARATOR

Vertistop D

Intervention Type: DIETARY_SUPPLEMENT

Food supplement containing alpha-lipoic acid, carnosine, zinc, vitamin D3 and vitamins of group B, 1 tablet/day before meals

Vertistop L

Patients with normal vitamin D levels (\>30 ng/mL, \>75 nmol/L)

Group Type: ACTIVE_COMPARATOR

Vertistop L

Intervention Type: DIETARY_SUPPLEMENT

Food supplement containing alpha-lipoic acid, carnosine, zinc and curcumin, 2 tablets/day (morning and evening)

Control group

Patients meeting the inclusion criteria with normal levels of vitamin D (\>30 ng/mL, \>75 nmol/L)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vertistop D

Food supplement containing alpha-lipoic acid, carnosine, zinc, vitamin D3 and vitamins of group B, 1 tablet/day before meals

Intervention Type: DIETARY_SUPPLEMENT

Vertistop L

Food supplement containing alpha-lipoic acid, carnosine, zinc and curcumin, 2 tablets/day (morning and evening)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Sanitaria Locale di Matera

OTHER

Sponsor Role: lead

Responsible Party

Prof. Giacinto Asprella Libonati

Medical Executive

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Policoro Hospital "Giovanni Paolo II"

Matera, , Italy

Countries

Italy

Other Identifiers

VERT-2017-001

Identifier Type: -

Identifier Source: org_study_id