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

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Brief Title

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)

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.
    


Study Type

Interventional


Primary Outcome

Number of BPPV recurrences in patients supplemented with Vertistop D

Secondary Outcome

 Number of BPPV recurrences in patients supplemented with Vertistop-L

Condition

Benign Paroxysmal Positional Vertigo (BPPV)

Intervention

Vertistop D

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

128

Start Date

December 4, 2018

Completion Date

November 3, 2020

Primary Completion Date

June 30, 2020

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.
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT04849182

Organization ID

VERT-2017-001


Responsible Party

Principal Investigator

Study Sponsor

Azienda Sanitaria Locale di Matera


Study Sponsor

, , 


Verification Date

April 2021