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

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.

Timeline

Start

2018-11-01

Primary completion

2019-09-30

Completion

2019-09-30

Publications

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

Drugs

Indications