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

Azienda Sanitaria Locale di Matera

Status: Completed

Conditions: Benign Paroxysmal Positional Vertigo (BPPV)

Treatments: Dietary Supplement: Vertistop D; Dietary Supplement: Vertistop L

Study type: Interventional

Funder types: Other

Identifiers

NCT04849182

VERT-2017-001

Details and patient eligibility

About

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)

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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128 participants in 3 patient groups

Vertistop D

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Vertistop D

Vertistop L

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Vertistop L

Control group

No Intervention group

Description:

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