Benign Paroxysmal Positional VertigoPhase 1NCT05748249
Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence
A Phase 1 study testing Vertistop® D in people with Benign Paroxysmal Positional Vertigo and Vitamin D, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo, Vitamin D, Antioxidants
- What is being tested?
- Vertistop® D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2018to 30 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)".
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.
Read the 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.
- Being tested
- Vertistop® D
- Medical subject headings
- Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertistop® DDrug
Also called Vertistop® L
Vitamin D supplementation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Vertistop® D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of BPPV recurrences in patients treated with Vertistop® D
Clinical Vestibular evaluation (presence of positional Nystagmus)
Measured: 6 months
Secondary outcomes (1)
Increased normalization of Vitamin D
Vitamin D evaluation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Nov 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Picciotti Pasqualina Maria, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Pasqualina M Picciotti, Principal investigator, Università Cattolica del Sacro Cuore, Fondazione Policlinico Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748249
- Sponsor's protocol ID
- VERT-2017-001
- Status last verified
- Feb 2023
- First submitted
- 10 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28248609Imai 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.
PubMed 27174206Epley JM. Positional vertigo related to semicircular canalithiasis. Otolaryngol Head Neck Surg. 1995 Jan;112(1):154-61. doi: 10.1016/S0194-59989570315-2.
PubMed 7816450von 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.
PubMed 17135456Eggers 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.
PubMed 31256095Buki 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.
PubMed 23245911Sheikhzadeh 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.
PubMed 27757201Taneja 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.
PubMed 24381922Elmoursy 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.
PubMed 34166965
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)".
- ClinicalTrials.gov ID
- NCT05748249
- Acronym / sponsor ID
- VERT-2017-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First arm Vertistop® L. | Active comparator | Drug: Vertistop® DBPPV 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. |
| 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 | Drug: Vertistop® DIn 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Patients under the age of 18.
- Secondary BPPV. Other causes of possible high recurrence BPPV and/or massive otolithic detachment:
- Patients with Vitamin D values exceeding 100 ng/mL (>250 nmol/L).
- Pregnant or lactating women, as reported by the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vertistop® DAlso: Vertistop® LVitamin D supplementation | Drug | First arm Vertistop® L., Third arm Vertistop® D |
Primary outcome
Change in the number of BPPV recurrences in patients treated with Vertistop® D
Time frame: 6 months
Clinical Vestibular evaluation (presence of positional Nystagmus)
1 secondary outcome
Increased normalization of Vitamin D
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Results publication: PubMed 28248609Bhattacharyya 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 publication: PubMed 27174206Imai 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 publication: PubMed 7816450Epley JM. Positional vertigo related to semicircular canalithiasis. Otolaryngol Head Neck Surg. 1995 Jan;112(1):154-61. doi: 10.1016/S0194-59989570315-2.
- Results publication: PubMed 17135456von 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 publication: PubMed 31256095Eggers 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 publication: PubMed 23245911Buki 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 publication: PubMed 27757201Sheikhzadeh 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 publication: PubMed 24381922Taneja 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 publication: PubMed 34166965Elmoursy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pasqualina M Picciotti principal investigator
Università Cattolica del Sacro Cuore, Fondazione Policlinico Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vertistop® D in people with Benign Paroxysmal Positional Vertigo and Vitamin D, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of BPPV recurrences in patients treated with Vertistop® D (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05748249, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.