Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence

NCT05748249 | Completed Phase 1

• 1 other identifier: VERT-2017-001
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The study involves the evaluation of 3 groups of subjects (3-arm study). Patients diagnosed with BPPV and "sufficient" serum concentrations of Vitamin D (\>30 ng/mL, \>75 nmol/L) at baseline may be treated with 2 tablets per day (morning and evening) of Vertistop® L ( Alpha-lipoic acid, carnosine, zinc and curcumin) or untreated, on the basis of the randomization criterion to which they will be assigned. Patients with Vitamin D "deficiency" (\<20 ng/mL, \<50 nmol/L) or Vitamin D "insufficient" (20-30 ng/mL, 50-75 nmol/L) at baseline, or subsequent follow-up, they will be treated for 2 months with Vertistop® D (alpha-lipoic acid, carnosine and zinc, vitamin D3 and vitamins of the B complex) taking 1 tablet a day (before meals). The main purpose of the study is to evaluate, over a period of 6 months, the efficacy of Vertistop® D and Vertistop® L supplementation in preventing recurrences of BPPV (Benign Paroxysmal Positional Vertigo), in relation to blood levels of Vitamin D.

Conditions

Benign Paroxysmal Positional Vertigo; Vitamin D; Antioxidants

Outcome Measures

Primary Outcomes (1)

• Change in the number of BPPV recurrences in patients treated with Vertistop® D

  Clinical Vestibular evaluation (presence of positional Nystagmus)

  6 months

Secondary Outcomes (1)

• Increased normalization of Vitamin D

  6 months

Other Outcomes (1)

• Evaluation of BPPV recurrences in patients treated with Vertistop® L.

  6 months

Study Arms (3)

First arm Vertistop® L.

ACTIVE COMPARATOR

BPPV patients will be assigned to the first arm have a "sufficient" serum concentration of Vitamin D between 31 and 100 ng/mL (76 and 250 nmol/L), which will be treated with Vertistop® L.

Drug: Vertistop® D

Second arm No Therapy

NO INTERVENTION

BPPV patients will be assigned to the second arm having serum concentrations of Vitamin D "Sufficient" between 31 and 100 ng/mL that will not be treated

Third arm Vertistop® D

EXPERIMENTAL

In the third arm, patients with serum values of Vitamin D "insufficient" i.e. between 20 and 30 ng/mL (50- 75 nmol/L) or "deficient" i.e. less than 20 ng/mL (50 nmol/L) which they will instead be treated with Vertistop® D.

Drug: Vertistop® D

Interventions

Vertistop® D DRUG

Vitamin D supplementation

Also known as: Vertistop® L

First arm Vertistop® L.; Third arm Vertistop® D

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes, aged between 18 and 85 years, diagnosed with primary BPPV.
• Patients who have BPPV of the posterior semicircular canal (SPC) geo and apo, lateral semicircular canal (SLC) geo and apo (single-canal, multi-canal).
• Patients with relapsing BPPV, defined as two or more episodes in the past six months, or three or more episodes in the last 12 months.
• Patients able to understand and follow the requirements of the Study Protocol and to provide their informed consent.

You may not qualify if:

• Patients under the age of 18.
• Secondary BPPV. Other causes of possible high recurrence BPPV and/or massive otolithic detachment:
• Migraine;
• Meniere's or delayed endolymphatic hydrops;
• Lindsay Hemenway syndrome;
• Otological and/or dental implant surgery in the last 3 months;
• Conclusion within 30 days.
• Patients with Vitamin D values exceeding 100 ng/mL (\>250 nmol/L).
• Pregnant or lactating women, as reported by the patient.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Clinica Otorinolaringoiatrica

Roma, 00168, Italy

Location

Related Publications (9)

• Bhattacharyya N, Gubbels SP, Schwartz SR, Edlow JA, El-Kashlan H, Fife T, Holmberg JM, Mahoney K, Hollingsworth DB, Roberts R, Seidman MD, Steiner RW, Do BT, Voelker CC, Waguespack RW, Corrigan MD. Clinical Practice Guideline: Benign Paroxysmal Positional Vertigo (Update). Otolaryngol Head Neck Surg. 2017 Mar;156(3_suppl):S1-S47. doi: 10.1177/0194599816689667.

  PMID: 28248609 RESULT

• Imai T, Takeda N, Ikezono T, Shigeno K, Asai M, Watanabe Y, Suzuki M; Committee for Standards in Diagnosis of Japan Society for Equilibrium Research. Classification, diagnostic criteria and management of benign paroxysmal positional vertigo. Auris Nasus Larynx. 2017 Feb;44(1):1-6. doi: 10.1016/j.anl.2016.03.013. Epub 2016 May 9.

  PMID: 27174206 RESULT

• Epley JM. Positional vertigo related to semicircular canalithiasis. Otolaryngol Head Neck Surg. 1995 Jan;112(1):154-61. doi: 10.1016/S0194-59989570315-2.

  PMID: 7816450 RESULT

• von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, Neuhauser H. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):710-5. doi: 10.1136/jnnp.2006.100420. Epub 2006 Nov 29.

  PMID: 17135456 RESULT

• Eggers SDZ, Bisdorff A, von Brevern M, Zee DS, Kim JS, Perez-Fernandez N, Welgampola MS, Della Santina CC, Newman-Toker DE. Classification of vestibular signs and examination techniques: Nystagmus and nystagmus-like movements. J Vestib Res. 2019;29(2-3):57-87. doi: 10.3233/VES-190658.

  PMID: 31256095 RESULT

• Buki B, Ecker M, Junger H, Lundberg YW. Vitamin D deficiency and benign paroxysmal positioning vertigo. Med Hypotheses. 2013 Feb;80(2):201-4. doi: 10.1016/j.mehy.2012.11.029. Epub 2012 Dec 14.

  PMID: 23245911 RESULT

• Sheikhzadeh M, Lotfi Y, Mousavi A, Heidari B, Bakhshi E. The effect of serum vitamin D normalization in preventing recurrences of benign paroxysmal positional vertigo: A case-control study. Caspian J Intern Med. 2016 Summer;7(3):173-177.

  PMID: 27757201 RESULT

• Taneja MK, Taneja V. Vitamin d deficiency in e.N.T. Patients. Indian J Otolaryngol Head Neck Surg. 2013 Jan;65(1):57-60. doi: 10.1007/s12070-012-0603-9. Epub 2012 Dec 1.

  PMID: 24381922 RESULT

• Elmoursy MM, Abbas AS. The role of low levels of vitamin D as a co-factor in the relapse of benign paroxysmal positional vertigo (BPPV). Am J Otolaryngol. 2021 Nov-Dec;42(6):103134. doi: 10.1016/j.amjoto.2021.103134. Epub 2021 Jun 19.

  PMID: 34166965 RESULT

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pasqualina M Picciotti

  Università Cattolica del Sacro Cuore, Fondazione Policlinico Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 28, 2023
• Study Start: November 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)