Clinical trial NCT04849182: Vertistop® D and Vertistop® L in Preventing Recurrence of High-recurrence BPPV
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Paroxysmal Positional Vertigo (BPPV)
Keywords: BPPV
Vertistop
Vitamin D
Alpha-lipoic acid
Zinc
Lead sponsor: Azienda Sanitaria Locale di Matera
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of BPPV recurrences in patients supplemented with Vertistop D
timeFrame: 0, 6 months
Secondary outcomes:
measure: Number of BPPV recurrences in patients supplemented with Vertistop-L
timeFrame: 0, 6 months
measure: Mean difference in Dizziness Handicap Inventory (DHI) values
timeFrame: 0, 6 months
measure: Mean difference in the Visual Numeric Scale (VNS) values
timeFrame: 0, 6 months
measure: Mean difference in the Visual Analogue Scale (VAS) values
timeFrame: 0, 6 months
Other outcomes:
measure: Incidence of adverse events
timeFrame: 2, 4, 6 months
Locations:
city: Matera
country: Italy
facility: Policoro Hospital "Giovanni Paolo II"
Study officials:
References: