Benign Paroxysmal Positional Vertigo (BPPV)NCT04849182
Vertistop® D and Vertistop® L in Preventing Recurrence of High-recurrence BPPV
A study testing Vertistop D and Vertistop L in people with Benign Paroxysmal Positional Vertigo (BPPV), run by Azienda Sanitaria Locale di Matera at 1 site in Italy.
Trial summary
Randomized, 3-arm controlled clinical study, to evaluate the effectiveness of supplementation with Vertistop® D (food supplement containing alpha-lipoic acid at modified release, Carnosine and Zinc, Vitamin D and Vitamins B) and Vertistop® L (food supplement containing fast releasing alpha-lipoic acid, Carnosine, Zinc… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo (BPPV)
- What is being tested?
- Vertistop D and Vertistop L
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 4 Dec 2018to 3 Nov 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary BPPV;
- Patients having BPPV of CSP or CSL (geo or apo, single or multi channel);
- Patients with recurrent BPPV, defined as two or more episodes over the last six months, or three or more episodes in the last 12 months;
- Informed consent.
Who cannot join
- Patients under 18 years of age;
- Secondary BPPV;
- Vitamin D levels greater than 100 ng/mL (>250 nmol/L);
- Pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, 3-arm Controlled Clinical Trial, Designed to Evaluate the Effectiveness of Supplementation With Vertistop® D and Vertistop® L in Preventing Recurrence of High-recurrence BPPV (Benign Paroxysmal Positional Vertigo)
Randomized, 3-arm controlled clinical study, to evaluate the effectiveness of supplementation with Vertistop® D (food supplement containing alpha-lipoic acid at modified release, Carnosine and Zinc, Vitamin D and Vitamins B) and Vertistop® L (food supplement containing fast releasing alpha-lipoic acid, Carnosine, Zinc and Curcumin) in preventing recurrence of high-recurrence BPPV (Benign Paroxysmal Positional Vertigo)
Read the detailed description
Benign paroxysmal positional vertigo (BPPV) is the most common type of vertigo detectable in otoneurological clinical practice. It is characterized by violent, short and relapsing vertiginous crises that arise when the patient assumes certain positions of the head in the space and is accompanied by a usually "typical" paroxysmal positional nystagmus. In most cases we cannot trace the exact causal agent, so we mainly identify two forms: primitive forms and secondary forms. BPPV therapy is essentially physical, and it is based on specific maneuvers which make the otoconial mass come out of the semicircular canal. Recent studies showed the existence of a seasonal trend of BPPV related to fluctuations in Vitamin D levels. Based on these considerations this clinical trial was designed in order to evaluate the possible efficacy of the administration of Vitamin D (Vertistop® D) in preventing recurrence of BPPV.
- Being tested
- Vertistop D, Vertistop L
- Keywords
- BPPV, Vertistop, Vitamin D, Alpha-lipoic acid, Zinc
- 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 DDietary supplement
Food supplement containing alpha-lipoic acid, carnosine, zinc, vitamin D3 and vitamins of group B, 1 tablet/day before meals
Vertistop LDietary supplement
Food supplement containing alpha-lipoic acid, carnosine, zinc and curcumin, 2 tablets/day (morning and evening)
| Study group | Role | What they receive |
|---|---|---|
| Vertistop D | Active comparator | Patients with deficiency (<20 ng/mL, <50 nmol/L) or insufficiency (20-30 ng/mL, 50-75 nmol/L) of Vitamin D Receives: Dietary Supplement: Vertistop D |
| Vertistop L | Active comparator | Patients with normal vitamin D levels (>30 ng/mL, >75 nmol/L) Receives: Dietary Supplement: Vertistop L |
| Control group | No intervention | Patients meeting the inclusion criteria with normal levels of vitamin D (>30 ng/mL, >75 nmol/L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of BPPV recurrences in patients supplemented with Vertistop D
Change in the number of BPPV recurrences associated with the increase or normalization of Vitamin D serum levels after supplementation with Vertistop D
Measured: 0, 6 months
Secondary outcomes (4)
Number of BPPV recurrences in patients supplemented with Vertistop-L
This parameter is defined as the difference in the number of BPPV recurrences observed in the period between the baseline visit and the final visit (after 6 months)
Measured: 0, 6 months
Mean difference in Dizziness Handicap Inventory (DHI) values
This parameter is defined as the mean difference in the DHI values between the baseline visit and the final visit (after 6 months)
Measured: 0, 6 months
Mean difference in the Visual Numeric Scale (VNS) values
This parameter is defined as the mean difference in the VNS values between the baseline visit and the final visit (after 6 months)
Measured: 0, 6 months
Mean difference in the Visual Analogue Scale (VAS) values
This parameter is defined as the mean difference in the VAS values between the baseline visit and the final visit (after 6 months)
Measured: 0, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start4 Dec 2018
- Primary completion30 Jun 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Paroxysmal Positional Vertigo (BPPV)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale di Matera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Giacinto Asprella Libonati, Azienda Sanitaria Locale di Matera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849182
- Sponsor's protocol ID
- VERT-2017-001
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, 3-arm Controlled Clinical Trial, Designed to Evaluate the Effectiveness of Supplementation With Vertistop® D and Vertistop® L in Preventing Recurrence of High-recurrence BPPV (Benign Paroxysmal Positional Vertigo)
- ClinicalTrials.gov ID
- NCT04849182
- Acronym / sponsor ID
- VERT-2017-001
- Keywords
- BPPV, Vertistop, Vitamin D, Alpha-lipoic acid, Zinc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale di MateraUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 19 Apr 2021 (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.
Randomized, 3-arm controlled clinical study, to evaluate the effectiveness of supplementation with Vertistop® D (food supplement containing alpha-lipoic acid at modified release, Carnosine and Zinc, Vitamin D and Vitamins B) and Vertistop® L (food supplement containing fast releasing alpha-lipoic acid, Carnosine, Zinc and Curcumin) in preventing recurrence of high-recurrence BPPV (Benign Paroxysmal Positional Vertigo)
Detailed description
Benign paroxysmal positional vertigo (BPPV) is the most common type of vertigo detectable in otoneurological clinical practice. It is characterized by violent, short and relapsing vertiginous crises that arise when the patient assumes certain positions of the head in the space and is accompanied by a usually "typical" paroxysmal positional nystagmus. In most cases we cannot trace the exact causal agent, so we mainly identify two forms: primitive forms and secondary forms. BPPV therapy is essentially physical, and it is based on specific maneuvers which make the otoconial mass come out of the semicircular canal. Recent studies showed the existence of a seasonal trend of BPPV related to fluctuations in Vitamin D levels. Based on these considerations this clinical trial was designed in order to evaluate the possible efficacy of the administration of Vitamin D (Vertistop® D) in preventing recurrence of BPPV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vertistop D | Active comparator | Dietary Supplement: Vertistop DPatients with deficiency (<20 ng/mL, <50 nmol/L) or insufficiency (20-30 ng/mL, 50-75 nmol/L) of Vitamin D |
| Vertistop L | Active comparator | Dietary Supplement: Vertistop LPatients with normal vitamin D levels (>30 ng/mL, >75 nmol/L) |
| Control group | No intervention | –Patients meeting the inclusion criteria with normal levels of vitamin D (>30 ng/mL, >75 nmol/L) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of primary BPPV;
- Patients having BPPV of CSP or CSL (geo or apo, single or multi channel);
- Patients with recurrent BPPV, defined as two or more episodes over the last six months, or three or more episodes in the last 12 months;
- Informed consent.
Key exclusion criteria (4 listed)
- Patients under 18 years of age;
- Secondary BPPV;
- Vitamin D levels greater than 100 ng/mL (>250 nmol/L);
- Pregnant or breastfeeding.
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 DFood supplement containing alpha-lipoic acid, carnosine, zinc, vitamin D3 and vitamins of group B, 1 tablet/day before meals | Dietary supplement | Vertistop D |
| Vertistop LFood supplement containing alpha-lipoic acid, carnosine, zinc and curcumin, 2 tablets/day (morning and evening) | Dietary supplement | Vertistop L |
Primary outcome
Number of BPPV recurrences in patients supplemented with Vertistop D
Time frame: 0, 6 months
Change in the number of BPPV recurrences associated with the increase or normalization of Vitamin D serum levels after supplementation with Vertistop D
4 secondary outcomes
Number of BPPV recurrences in patients supplemented with Vertistop-L
Time frame: 0, 6 months
Mean difference in Dizziness Handicap Inventory (DHI) values
Time frame: 0, 6 months
Mean difference in the Visual Numeric Scale (VNS) values
Time frame: 0, 6 months
Mean difference in the Visual Analogue Scale (VAS) values
Time frame: 0, 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 22 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertistop D and Vertistop L in people with Benign Paroxysmal Positional Vertigo (BPPV), run by Azienda Sanitaria Locale di Matera 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 4 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 22 Apr 2021. 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.
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?
Number of BPPV recurrences in patients supplemented with Vertistop D (time frame: 0, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2021.