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BPPVNCT05863949

Clinical Trial of Vit D and Calcium for Recurrent BPPV

A study testing vitamin D +/- calcium in people with BPPV and Benign Paroxysmal Positional Vertigo, run by Ottawa Hospital Research Institute.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Randomized double blind placebo controlled trial of vitamin D supplements, with or without calcium supplementation, versus placebo in reduction of recurrences in BPPV. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
vitamin D +/- calcium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
860 participants
Where
No sites listed yet
Study dates
Aug 2025to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Age 18 years or older
  • 2 or more distinct episodes of benign paroxysmal positional vertigo within a 12-month period on history
  • At least 1 episode diagnosed based on physical examination by trained study personnel, meeting the diagnostic criteria of the Bárány Society
  • Episodes separated in time, with a minimum of 1 week symptom-free between episodes
  • Serum evidence of Vitamin D deficiency, as evidenced by 25-hydroxy vitamin D level of <75 nmol/L (<30 ng/mL)48
  • Subject able to provide informed consent to participate in the study

Who cannot join

  • Potential subjects will be excluded if they
  • have another identifiable cause of vertigo identified on history or physical examination
  • have a history of allergy or medically significant adverse reaction to vitamin D or calcium carbonate
  • have a chronic medical disorder which is a contraindication to vitamin D or calcium carbonate supplementation, including uncontrolled hyperparathyroidism, nephrolithiasis, or GI malabsorption disorders
  • are on loop diuretic agents or thiazides
  • have a contraindication to routine bloodwork for study purposes, including being hospitalized with a critical illness, cellulitis at blood draw sites, or presence of vascular grafts.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: STOP Vertigo: Supplementation of Vitamin D for Termination of Recurrences From Benign Paroxysmal Positional Vertigo

Randomized double blind placebo controlled trial of vitamin D supplements, with or without calcium supplementation, versus placebo in reduction of recurrences in BPPV.

Read the detailed description

Benign paroxysmal positional vertigo (BPPV) is the most common neuro-otological disorder, with a lifetime prevalence of 2.4 percent.1 BPPV is responsible for nearly one-half of cases of peripheral vestibular dysfunction. It is a highly recurrent disorder, with more than 1 in 4 patients experiencing a second attack, often within 6 months of the first.2-4 According to the Clinical Practice Guidelines for BPPV from the American Academy of Otolaryngology-Head and Neck Surgery Foundation, particle repositioning maneuvers (PRMs) are the only recommended treatment to resolve symptoms for both initial BPPV episodes as well as persistent episodes.5 While attacks can be effectively treated by PRMs, these often must be performed by a physician or other trained healthcare professional, and sometimes multiple attempts are required in order to successfully resolve a patient's symptoms. Furthermore, even with effective particle repositioning, a subset of patients may continue to experience bouts of recurrent attacks, up to several times yearly. The attacks themselves, as well as the nature of their treatment, - especially in patients with recurrent episodes - are prone to lead to interruptions in patients' daily activities, cause sick leaves, and result in significant direct and indirect costs to both the patient and the healthcare system.6 The prevalence of BPPV increases with age and elderly patients with BPPV are more likely to have reduced activities of daily living (ADL) scores, sustain falls, and suffer from depression.4,7 In the United States (US), more than sixty-five percent of patients with BPPV experience potentially avoidable diagnostic testing or therapeutic interventions during the time leading up to a proper diagnosis, costing the US health care system nearly $2 billion per year.5

BPPV is widely accepted to be caused by otoconia that are dislodged from the utricular macula into the semicircular canals - most commonly the posterior canal.8 Otoconia are made of a largely organic core of glycoproteins, with a predominantly inorganic periphery of calcium carbonate.9 Otoconia form within the otherwise low-calcium endolymph via an active, tightly controlled and ordered process.10 Recent studies have shown that the biomineralization of otoconia has similarities to that of bone and teeth, and that bone metabolism has a connection to BPPV. 11-13 Furthermore, an association has been demonstrated between BPPV and osteoporosis, and otoconia formation has been shown to be dysfunctional in animal models of osteoporosis.14,15

The impact of recurrent BPPV on both patients and the healthcare system is multiplicative. With each episode of recurrence, patients become symptomatic - potentially severely so - and must seek treatment again in the form of particle repositioning maneuvers. These patients therefore suffer further functional impairment, potentially missed school and work, and require healthcare interventions which are not without cost to the system. No preventative treatment option for recurrent BPPV exists. Establishing such a preventative treatment would have significant implications in reducing both direct and indirect costs of this highly prevalent and recurrent disorder.

Vitamin D is involved in bodily calcium regulation, and thus poses an attractive potential treatment for BPPV. Vitamin D deficiency is common in many regions worldwide, and supplementation carries little risk. A body of literature has emerged to date investigating potential links between vitamin D deficiency and BPPV - especially recurrent - and whether vitamin D supplementation could in turn serve some role in treatment or prevention.

Being tested
vitamin D +/- calcium, Placebo
Keywords
bppv, benign paroxysmal positional vertigo, vertigo, dizziness, vitamin D
Medical subject headings
Benign Paroxysmal Positional Vertigo, Vertigo, Dizziness, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vitamin D +/- calciumDietary supplement

    vitamin D 1000iU daily +/- calcium 500mg BID daily

  • PlaceboOther

    placebo pill x3 daily

Study groups in NCT05863949
Study groupRoleWhat they receive
vitamin D +/- calcium supplementationExperimentalpatients given Vitamin D 1000iu daily. Also given calcium 500mg BID daily if calcium deficient.
Receives: Dietary Supplement: vitamin D +/- calcium
Placebo armPlacebo comparatorpatients given 3 pills of placebo daily.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence rate of BPPV

    how many recurrences of BPPV

    Measured: 1 year

Secondary outcomes (7)
  1. serum vitamin D levels (25(OH)D3)

    serum vitamin D levels

    Measured: 1 year

  2. proportion of serum vitamin D normalization

    do patients normalize

    Measured: 1 year

  3. time to serum vitamin D normalization

    how long does it take patients to normalize

    Measured: 1 year

  4. proportion of recurrences

    what proportion of total patients have recurrences

    Measured: 1 year

  5. duration of recurrences

    how long do recurrences of BPPV last

    Measured: 1 year

  6. EQ-5D

    quality of life measurement

    Measured: 1 year

  7. days per year of missed school/work

    days per year of missed school/work

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2023
  2. Study startAug 2025 (estimated)
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is an off-label, multicenter, randomized, clinical trial in vitamin D deficient adults aged 18 and above with recurrent BPPV. Its goal is to determine whether vitamin D supplementation, with or without calcium supplementation, compared with placebo will decrease the frequency of recurrent episodes of BPPV. A total of 860 vitamin D deficient adults diagnosed with recurrent BPPV will be enrolled at participating clinical study sites.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
860 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05863949
Sponsor's protocol ID
20220451-01T
Status last verified
Jun 2025
First submitted
28 Apr 2023
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • von Brevern M, Bertholon P, Brandt T, Fife T, Imai T, Nuti D, Newman-Toker D. Benign paroxysmal positional vertigo: Diagnostic criteria. J Vestib Res. 2015;25(3-4):105-17. doi: 10.3233/VES-150553.

    PubMed 26756126
  • Luryi AL, Lawrence J, Bojrab DI, LaRouere M, Babu S, Zappia J, Sargent EW, Chan E, Naumann I, Hong RS, Schutt CA. Recurrence in Benign Paroxysmal Positional Vertigo: A Large, Single-Institution Study. Otol Neurotol. 2018 Jun;39(5):622-627. doi: 10.1097/MAO.0000000000001800.

    PubMed 29649052
  • Perez P, Franco V, Cuesta P, Aldama P, Alvarez MJ, Mendez JC. Recurrence of benign paroxysmal positional vertigo. Otol Neurotol. 2012 Apr;33(3):437-43. doi: 10.1097/MAO.0b013e3182487f78.

    PubMed 22388730
  • Zhu CT, Zhao XQ, Ju Y, Wang Y, Chen MM, Cui Y. Clinical Characteristics and Risk Factors for the Recurrence of Benign Paroxysmal Positional Vertigo. Front Neurol. 2019 Nov 13;10:1190. doi: 10.3389/fneur.2019.01190. eCollection 2019.

    PubMed 31798518
  • 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 28248609
  • von 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 17135456
  • Oghalai JS, Manolidis S, Barth JL, Stewart MG, Jenkins HA. Unrecognized benign paroxysmal positional vertigo in elderly patients. Otolaryngol Head Neck Surg. 2000 May;122(5):630-4. doi: 10.1016/S0194-5998(00)70187-2.

    PubMed 10793337
  • Parnes LS, Agrawal SK, Atlas J. Diagnosis and management of benign paroxysmal positional vertigo (BPPV). CMAJ. 2003 Sep 30;169(7):681-93.

    PubMed 14517129
  • Lins U, Farina M, Kurc M, Riordan G, Thalmann R, Thalmann I, Kachar B. The otoconia of the guinea pig utricle: internal structure, surface exposure, and interactions with the filament matrix. J Struct Biol. 2000 Jul;131(1):67-78. doi: 10.1006/jsbi.2000.4260.

    PubMed 10945971
  • Lundberg YW, Zhao X, Yamoah EN. Assembly of the otoconia complex to the macular sensory epithelium of the vestibule. Brain Res. 2006 May 26;1091(1):47-57. doi: 10.1016/j.brainres.2006.02.083. Epub 2006 Apr 4.

    PubMed 16600187
  • Zhao X, Yang H, Yamoah EN, Lundberg YW. Gene targeting reveals the role of Oc90 as the essential organizer of the otoconial organic matrix. Dev Biol. 2007 Apr 15;304(2):508-24. doi: 10.1016/j.ydbio.2007.01.013. Epub 2007 Jan 12.

    PubMed 17300776
  • Xu Y, Zhang H, Yang H, Zhao X, Lovas S, Lundberg YW. Expression, functional, and structural analysis of proteins critical for otoconia development. Dev Dyn. 2010 Oct;239(10):2659-73. doi: 10.1002/dvdy.22405.

    PubMed 20803598
  • Jeong SH, Choi SH, Kim JY, Koo JW, Kim HJ, Kim JS. Osteopenia and osteoporosis in idiopathic benign positional vertigo. Neurology. 2009 Mar 24;72(12):1069-76. doi: 10.1212/01.wnl.0000345016.33983.e0.

    PubMed 19307540
  • Vibert D, Kompis M, Hausler R. Benign paroxysmal positional vertigo in older women may be related to osteoporosis and osteopenia. Ann Otol Rhinol Laryngol. 2003 Oct;112(10):885-9. doi: 10.1177/000348940311201010.

    PubMed 14587980
  • Vibert D, Sans A, Kompis M, Travo C, Muhlbauer RC, Tschudi I, Boukhaddaoui H, Hausler R. Ultrastructural changes in otoconia of osteoporotic rats. Audiol Neurootol. 2008;13(5):293-301. doi: 10.1159/000124277. Epub 2008 Apr 7.

    PubMed 18391565

Questions about this trial

What is this clinical trial studying?

A study testing vitamin D +/- calcium in people with BPPV and Benign Paroxysmal Positional Vertigo, run by Ottawa Hospital Research Institute.

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 6 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: opening soon, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Darren Tse, MD (6137997838 ext. 13360, dtse88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence rate of BPPV (time frame: 1 year). 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 NCT05863949, which also lists 43 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 25 Jun 2025.

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