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

Primary Purpose

Benign Paroxysmal Positional Vertigo, Vitamin D, Antioxidants

Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Vertistop® D
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Benign Paroxysmal Positional Vertigo

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Clinica Otorinolaringoiatrica

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Experimental

Arm Label

First arm Vertistop® L.

Second arm No Therapy

Third arm Vertistop® D

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

Change in the number of BPPV recurrences in patients treated with Vertistop® D
Clinical Vestibular evaluation (presence of positional Nystagmus)

Secondary Outcome Measures

Increased normalization of Vitamin D
Vitamin D evaluation

Full Information

First Posted
February 10, 2023
Last Updated
February 24, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05748249
Brief Title
Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence
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)".
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo, Vitamin D, Antioxidants

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First arm Vertistop® L.
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Second arm No Therapy
Arm Type
No Intervention
Arm Description
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
Arm Title
Third arm Vertistop® D
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vertistop® D
Other Intervention Name(s)
Vertistop® L
Intervention Description
Vitamin D supplementation
Primary Outcome Measure Information:
Title
Change in the number of BPPV recurrences in patients treated with Vertistop® D
Description
Clinical Vestibular evaluation (presence of positional Nystagmus)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Increased normalization of Vitamin D
Description
Vitamin D evaluation
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Evaluation of BPPV recurrences in patients treated with Vertistop® L.
Description
Clinical vestibular evaluation (presence of positional Nystagmus)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pasqualina M Picciotti
Organizational Affiliation
Università Cattolica del Sacro Cuore, Fondazione Policlinico Gemelli IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Otorinolaringoiatrica
City
Roma
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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28248609
Citation
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Results Reference
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PubMed Identifier
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Citation
Epley JM. Positional vertigo related to semicircular canalithiasis. Otolaryngol Head Neck Surg. 1995 Jan;112(1):154-61. doi: 10.1016/S0194-59989570315-2.
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PubMed Identifier
17135456
Citation
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Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence

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