Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: First arm Vertistop® L. 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
Vitamin D supplementation
Other Names:
|
| No Intervention: Second arm No Therapy 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 |
|
| Experimental: Third arm Vertistop® D 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
Vitamin D supplementation
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in the number of BPPV recurrences in patients treated with Vertistop® D [6 months]
Clinical Vestibular evaluation (presence of positional Nystagmus)
Secondary Outcome Measures
- Increased normalization of Vitamin D [6 months]
Vitamin D evaluation
Other Outcome Measures
- Evaluation of BPPV recurrences in patients treated with Vertistop® L. [6 months]
Clinical vestibular evaluation (presence of positional Nystagmus)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients of both sexes, aged between 18 and 85 years, diagnosed with primary BPPV.
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Patients who have BPPV of the posterior semicircular canal (SPC) geo and apo, lateral semicircular canal (SLC) geo and apo (single-canal, multi-canal).
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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.
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Patients able to understand and follow the requirements of the Study Protocol and to provide their informed consent.
Exclusion Criteria:
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Patients under the age of 18.
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Secondary BPPV. Other causes of possible high recurrence BPPV and/or massive otolithic detachment:
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Migraine;
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Meniere's or delayed endolymphatic hydrops;
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Lindsay Hemenway syndrome;
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Otological and/or dental implant surgery in the last 3 months;
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Conclusion within 30 days.
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Patients with Vitamin D values exceeding 100 ng/mL (>250 nmol/L).
-
Pregnant or lactating women, as reported by the patient.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinica Otorinolaringoiatrica | Roma | Italy | 00168 |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
- Principal Investigator: Pasqualina M Picciotti, Università Cattolica del Sacro Cuore, Fondazione Policlinico Gemelli IRCCS
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VERT-2017-001