Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05748249

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

Benign Paroxysmal Positional Vertigo Clinical Trial

Official title:
"Randomized, Controlled 3-arm Clinical Study to Evaluate the Efficacy of Supplementation With Vertistop® D and Vertistop® L in Preventing Recurrences of Highly Recurring BPPV (Benign Paroxysmal Positional Vertigo)".

Clinical Trial 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.

Clinical Trial Description

Patients will be assigned to one of the three study groups following a randomization list with reference to groups 1 and 2 and according to the serum concentrations of 25(OH) Vitamin D, evaluated at the baseline visit, with reference to group 3. The determination of the Vitamin D concentration will be requested by the Investigating physician and the report will be evaluated during the randomisation visit (V1), Visit 2, (after 2 months from enrollment/start of treatment), Visit 3 (Follow-up visit up to 4 months from enrollment) and finally Visit 4 (Follow-up visit 6 months after enrollment). The blood sample and the Vitamin D dosage will be carried out the week before the day of the visit agreed with the Investigator, in a trusted laboratory of the patient, provided that it has the legal authorizations and the analytical methodology satisfactory the measurement intervals reported in Protocol. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05748249
Study type Interventional
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact
Status Completed
Phase Phase 1
Start date November 1, 2018
Completion date September 30, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT03425786 - Benign Paroxysmal Positional Vertigo (BPPV) Training for Sports Medicine Providers in a Pediatric Concussion Program N/A
Completed NCT02046980 - Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo Phase 2
Withdrawn NCT00978809 - Effects of Physical Treatment on Postural Stability in Benign Paroxysmal Positional Vertigo (BPPV) Patients N/A
Completed NCT02029508 - The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo Phase 3
Completed NCT02809599 - Evidence Based Best Care Practice for Benign Paroxysmal Positional Vertigo N/A
Completed NCT03230513 - Comparison of Home-Based Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms N/A
Completed NCT03643354 - Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy Using the Rotundum Device in Retirement Homes N/A
Completed NCT00641797 - Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients N/A
Recruiting NCT06001047 - Head Acupuncture Treat Residual Symptoms After Canalith Repositioning Procedure for BPPV N/A
Not yet recruiting NCT04578262 - Epley Manoeuvre in Participants With Multiple Sclerosis Diagnosed From Benign Paroxysmal Positional Vertigo N/A
Not yet recruiting NCT04578470 - Benign Paroxysmal Positional Vertigo (BPPV) in Older Patients Phase 2
Active, not recruiting NCT06314581 - Effect of a Multifaceted Educational Intervention on the Implementation of Evidence-based Practices for Benign Paroxysmal Positional Vertigo in an Emergency Department
Completed NCT04715282 - The Epley Maneuver Versus Cawthorne-Cooksey Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV) N/A
Terminated NCT03161470 - Efficacy of a Mechanical Chair for Treatment of Benign Paroxysmal Positional Vertigo (BPPV) N/A
Completed NCT05425199 - Habituation Exercises Versus Proprioceptive Training in Benign Paroxysmal Positional Vertigo N/A
Recruiting NCT05922774 - Cervical Vestibular Evoked Myogenic Potentials in Recurrent and Persistant Benign Paroxysmal Positional Vertigo
Recruiting NCT05013684 - Benign Paroxysmal Positional Vertigo in Older Adults N/A
Not yet recruiting NCT05863949 - Clinical Trial of Vit D and Calcium for Recurrent BPPV N/A
Suspended NCT04026516 - CAVA: Dizziness Trial N/A
Completed NCT05127694 - Treatment In Acute Benign Paroxysmal Positional Vertigo N/A