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Completed

NCT Number: NCT04849182

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

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)

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policoro Hospital "Giovanni Paolo II"

Matera, 75100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vertistop D

Dietary Supplement

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

Vertistop L

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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 outcomes

  1. Incidence of adverse events

    Time frame: 2, 4, 6 months

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale di Matera

Other

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 19, 2021
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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