Benign Paroxismal Positional VertigoEarly Phase 1RR-BPPV-DKNCT07861464
BPPV Recurrence After CRM With & Without Supplementation
A Early Phase 1 study testing Combined vitamin D₃ and K₂ supplementation, Vitamin D₃ alone and Canalith repositioning maneuver (CRM) alone in people with Benign Paroxismal Positional Vertigo, run by University of Jordan at 1 site in Jordan.
Trial summary
Benign paroxysmal positional vertigo (BPPV) may frequently recur even after successful canalith repositioning maneuvers (CRMs). This study investigates whether the addition of vitamin K₂ to vitamin D₃ offers additional benefits for reducing recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Paroxismal Positional Vertigo
- What is being tested?
- Combined vitamin D₃ and K₂ supplementation, Vitamin D₃ alone and Canalith repositioning maneuver (CRM) alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jan 2025to 31 Aug 2026
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with a confirmed diagnosis of BPPV.
- Had been successfully treated with a repositioning maneuver.
- Had normal renal and hepatic function.
Who cannot join
- If they had secondary BPPV due to head or ear trauma, surgery, or ear infection within the previous month.
- If they have had chronic systemic diseases (renal, pulmonary, hemato-logic, gastrointestinal, or cardiovascular).
- If they have had current use of calcium or vitamin D3 or vitamin K2 supplements or medications affecting vitamin D3 metabolism within the last year.
- If they have had active inner ear disease.
- If they have had incomplete research data.
- If consent was not provided.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benign Paroxysmal Positional Vertigo Recurrence After Canalith Re-positioning: A 12-Month Prospective Cohort Comparison of Vitamin D₃ Plus K₂, Vitamin D₃ Alone, and Maneuver Alone.
Benign paroxysmal positional vertigo (BPPV) may frequently recur even after successful canalith repositioning maneuvers (CRMs). This study investigates whether the addition of vitamin K₂ to vitamin D₃ offers additional benefits for reducing recurrence. It involved 404 adults treated at a single otolaryngology center in Amman, Jordan, divided into three groups: combined D3K2 (n = 212), D3 alone (n = 105), and CRM alone (n = 87). The study used modified Poisson regression to analyze 12-month recurrence rates, adjusting for confounding factors. Recurrence was clinically confirmed during the follow-up period.
Read the detailed description
Benign paroxysmal positional vertigo (BPPV) frequently recurs after successful canalith repositioning maneuvers (CRMs). Vitamin D deficiency has been linked to recurrence, but whether adding vitamin K₂ to vitamin D₃ provides additional benefit remains uncertain. We compared 12-month BPPV recurrence among patients receiving combined vitamin D₃ and K₂ (D3K2), vitamin D₃ alone (D3), or CRM alone, and examined whether the association differed by BPPV subtype.
This prospective, nonrandomized cohort study included 404 adults successfully treated with a CRM at a single otolar-yngology center in Amman, Jordan. Treatment was not randomly allocated; participants formed a convenience sample and received D3K2 (n = 212), D3 alone (n = 105), or CRM alone (n = 87). Recurrence was clinically confirmed during 12 months of follow-up. Modified Poisson regression with robust variance estimated risk ratios (RRs), adjusting for age, sex, and BPPV subtype.
- Conditions
- Benign Paroxismal Positional Vertigo
- Being tested
- Combined vitamin D₃ and K₂ supplementation, Vitamin D₃ alone, Canalith repositioning maneuver (CRM) alone
- Keywords
- BPPV, Vitamin D₃ Deficiency, Vitamins D₃ and K₂ supplementation, Canalith Repositioning Maneuver (CRM), Recurrent Vertigo
- Medical subject headings
- Vitamin D Deficiency, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined vitamin D₃ and K₂ supplementationDrug
All patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM) and received combined vitamin D₃ and K₂ supplementation. Then they were followed for 12 months, during which recurrent attacks of BPPV were recorded.
The combined regimen consisted of cholecalciferol 4000 IU daily and men-aquinone-7 (MK-7) 200 μg daily for 12 months. The MK-7 dose was selected on the basis of prior clinical work showing enhanced carboxylation of vitamin K-dependent proteins.
Vitamin D₃ aloneDrug
All patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM) and received vitamin D₃ only supplementation (4000 IU daily for 12 months). Then they were followed for 12 months, during which recurrent attacks of BPPV were recorded.
Canalith repositioning maneuver (CRM) aloneProcedure or surgery
All patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM)
| Study group | Role | What they receive |
|---|---|---|
| Canalith repositioning maneuver plus vitamin D₃ alone (D3; n = 105) | Active comparator | All patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM) and received vitamin D₃ only supplementation (4000 IU daily for 12 months). Then they were followed for 12 months, during which recurrent attacks of BPPV were recorded. Receives: Drug: Vitamin D₃ alone; Procedure: Canalith repositioning maneuver (CRM) alone |
| Canalith repositioning maneuver plus vitamin D₃ and vitamin K₂ supplementation (D3K2; n = 212) | Experimental | All patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM) and received combined vitamin D₃ and K₂ supplementation. Then they were followed for 12 months, during which recurrent attacks of BPPV were recorded.
The combined regimen consisted of cholecalciferol 4000 IU daily and men-aquinone-7 (MK-7) 200 μg daily for 12 months. The MK-7 dose was selected on the basis of prior clinical work showing enhanced carboxylation of vitamin K-dependent proteins. Receives: Drug: Combined vitamin D₃ and K₂ supplementation; Procedure: Canalith repositioning maneuver (CRM) alone |
| Canalith repositioning maneuver only (CRM only; n = 87) | Active comparator | All patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM) alone without receiving any supplementation. Then they were followed for 12 months, during which recurrent attacks of BPPV were recorded. Receives: Procedure: Canalith repositioning maneuver (CRM) alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of BPPV
The recurrence rate of BPPV within one year after the initial clinical visit
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Jan 2025
- Primary completion1 Jul 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Benign Paroxismal Positional VertigoStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, nonrandomized cohort study.
- Masking
- None (open label)
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alia A. Alghwiri, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861464
- Sponsor's protocol ID
- 373-2025
- Acronym
- RR-BPPV-DK
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the following will be shared in the publised paper: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
Publications
McClure JA. Horizontal canal BPV. J Otolaryngol. 1985 Feb;14(1):30-5.
PubMed 4068089Epley JM. The canalith repositioning procedure: for treatment of benign paroxysmal positional vertigo. Otolaryngol Head Neck Surg. 1992 Sep;107(3):399-404. doi: 10.1177/019459989210700310.
PubMed 1408225Epley JM. New dimensions of benign paroxysmal positional vertigo. Otolaryngol Head Neck Surg (1979). 1980 Sep-Oct;88(5):599-605. doi: 10.1177/019459988008800514.
PubMed 7443266Hall SF, Ruby RR, McClure JA. The mechanics of benign paroxysmal vertigo. J Otolaryngol. 1979 Apr;8(2):151-8.
PubMed 430582Schuknecht HF. Cupulolithiasis. Arch Otolaryngol. 1969 Dec;90(6):765-78. doi: 10.1001/archotol.1969.00770030767020. No abstract available.
PubMed 5353084DIX MR, HALLPIKE CS. The pathology symptomatology and diagnosis of certain common disorders of the vestibular system. Proc R Soc Med. 1952 Jun;45(6):341-54. doi: 10.1177/003591575204500604. No abstract available.
PubMed 14941845Bárány, E. Diagnose yon krankheitserscheinungen im bereiche des otolithenapparates. Acta Oto-Laryngologica. 1920, 2, 434-437. [DOI: 10.3109/00016482009123103]
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benign Paroxysmal Positional Vertigo Recurrence After Canalith Re-positioning: A 12-Month Prospective Cohort Comparison of Vitamin D₃ Plus K₂, Vitamin D₃ Alone, and Maneuver Alone.
- ClinicalTrials.gov ID
- NCT07861464
- Acronym / sponsor ID
- RR-BPPV-DK / 373-2025
- Conditions
- Benign Paroxismal Positional Vertigo
- Keywords
- BPPV, Vitamin D₃ Deficiency, Vitamins D₃ and K₂ supplementation, Canalith Repositioning Maneuver (CRM), Recurrent Vertigo
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 6 Oct 2026 (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.
Benign paroxysmal positional vertigo (BPPV) may frequently recur even after successful canalith repositioning maneuvers (CRMs). This study investigates whether the addition of vitamin K₂ to vitamin D₃ offers additional benefits for reducing recurrence. It involved 404 adults treated at a single otolaryngology center in Amman, Jordan, divided into three groups: combined D3K2 (n = 212), D3 alone (n = 105), and CRM alone (n = 87). The study used modified Poisson regression to analyze 12-month recurrence rates, adjusting for confounding factors. Recurrence was clinically confirmed during the follow-up period.
Detailed description
Benign paroxysmal positional vertigo (BPPV) frequently recurs after successful canalith repositioning maneuvers (CRMs). Vitamin D deficiency has been linked to recurrence, but whether adding vitamin K₂ to vitamin D₃ provides additional benefit remains uncertain. We compared 12-month BPPV recurrence among patients receiving combined vitamin D₃ and K₂ (D3K2), vitamin D₃ alone (D3), or CRM alone, and examined whether the association differed by BPPV subtype.
This prospective, nonrandomized cohort study included 404 adults successfully treated with a CRM at a single otolar-yngology center in Amman, Jordan. Treatment was not randomly allocated; participants formed a convenience sample and received D3K2 (n = 212), D3 alone (n = 105), or CRM alone (n = 87). Recurrence was clinically confirmed during 12 months of follow-up. Modified Poisson regression with robust variance estimated risk ratios (RRs), adjusting for age, sex, and BPPV subtype.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a prospective, nonrandomized cohort study.
| Arm | Type | Receives |
|---|---|---|
| Canalith repositioning maneuver plus vitamin D₃ alone (D3; n = 105) | Active comparator | Drug: Vitamin D₃ alone, Procedure: Canalith repositioning maneuver (CRM) aloneAll patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM) and received vitamin D₃ only supplementation (4000 IU daily for 12 months). Then they were followed for 12 months, during which recurrent attacks of BPPV were recorded. |
| Canalith repositioning maneuver plus vitamin D₃ and vitamin K₂ supplementation (D3K2; n = 212) | Experimental | Drug: Combined vitamin D₃ and K₂ supplementation, Procedure: Canalith repositioning maneuver (CRM) aloneAll patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM) and received combined vitamin D₃ and K₂ supplementation. Then they were followed for 12 months, during which recurrent attacks of BPPV were recorded. The combined regimen consisted of cholecalciferol 4000 IU daily and men-aquinone-7 (MK-7) 200 μg daily for 12 months. The MK-7 dose was selected on the basis of prior clinical work showing enhanced carboxylation of vitamin K-dependent proteins. |
| Canalith repositioning maneuver only (CRM only; n = 87) | Active comparator | Procedure: Canalith repositioning maneuver (CRM) aloneAll patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM) alone without receiving any supplementation. Then they were followed for 12 months, during which recurrent attacks of BPPV were recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with a confirmed diagnosis of BPPV.
- Had been successfully treated with a repositioning maneuver.
- Had normal renal and hepatic function.
Key exclusion criteria (6 listed)
- If they had secondary BPPV due to head or ear trauma, surgery, or ear infection within the previous month.
- If they have had chronic systemic diseases (renal, pulmonary, hemato-logic, gastrointestinal, or cardiovascular).
- If they have had current use of calcium or vitamin D3 or vitamin K2 supplements or medications affecting vitamin D3 metabolism within the last year.
- If they have had active inner ear disease.
- If they have had incomplete research data.
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 |
|---|---|---|
| Combined vitamin D₃ and K₂ supplementationAll patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM) and received combined vitamin D₃ and K₂ supplementation. Then they were followed for 12 months, during which recurrent attacks of BPPV were recorded. The combined regimen consisted of cholecalciferol 4000 IU daily and men-aquinone-7 (MK-7) 200 μg daily for 12 months. The MK-7 dose was selected on the basis of prior clinical work showing enhanced carboxylation of vitamin K-dependent proteins. | Drug | Canalith repositioning maneuver plus vitamin D₃ and vitamin K₂ supplementation (D3K2; n = 212) |
| Vitamin D₃ aloneAll patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM) and received vitamin D₃ only supplementation (4000 IU daily for 12 months). Then they were followed for 12 months, during which recurrent attacks of BPPV were recorded. | Drug | Canalith repositioning maneuver plus vitamin D₃ alone (D3; n = 105) |
| Canalith repositioning maneuver (CRM) aloneAll patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM) | Procedure or surgery | Canalith repositioning maneuver only (CRM only; n = 87), Canalith repositioning maneuver plus vitamin D₃ alone (D3; n = 105), Canalith repositioning maneuver plus vitamin D₃ and vitamin K₂ supplementation (D3K2; n = 212) |
Primary outcome
Recurrence rate of BPPV
Time frame: 12 months
The recurrence rate of BPPV within one year after the initial clinical visit
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 6 Oct 2026.
- Background: PubMed 4068089McClure JA. Horizontal canal BPV. J Otolaryngol. 1985 Feb;14(1):30-5.
- Background: PubMed 1408225Epley JM. The canalith repositioning procedure: for treatment of benign paroxysmal positional vertigo. Otolaryngol Head Neck Surg. 1992 Sep;107(3):399-404. doi: 10.1177/019459989210700310.
- Background: PubMed 7443266Epley JM. New dimensions of benign paroxysmal positional vertigo. Otolaryngol Head Neck Surg (1979). 1980 Sep-Oct;88(5):599-605. doi: 10.1177/019459988008800514.
- Background: PubMed 430582Hall SF, Ruby RR, McClure JA. The mechanics of benign paroxysmal vertigo. J Otolaryngol. 1979 Apr;8(2):151-8.
- Background: PubMed 5353084Schuknecht HF. Cupulolithiasis. Arch Otolaryngol. 1969 Dec;90(6):765-78. doi: 10.1001/archotol.1969.00770030767020. No abstract available.
- Background: PubMed 14941845DIX MR, HALLPIKE CS. The pathology symptomatology and diagnosis of certain common disorders of the vestibular system. Proc R Soc Med. 1952 Jun;45(6):341-54. doi: 10.1177/003591575204500604. No abstract available.
- BackgroundBárány, E. Diagnose yon krankheitserscheinungen im bereiche des otolithenapparates. Acta Oto-Laryngologica. 1920, 2, 434-437. [DOI: 10.3109/00016482009123103]
- The data set for all patients is with the primary investigator and can be reached by sending a request with the appropriate justifications.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All the following will be shared in the publised paper: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
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 Early Phase 1 study testing Combined vitamin D₃ and K₂ supplementation, Vitamin D₃ alone and Canalith repositioning maneuver (CRM) alone in people with Benign Paroxismal Positional Vertigo, run by University of Jordan at 1 site in Jordan.
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 3 inclusion and 6 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 6 Oct 2026. 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 Jordan. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Recurrence rate of BPPV (time frame: 12 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 NCT07861464, which also lists 7 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 6 Oct 2026.