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Not yet recruiting NCT05863949

Clinical Trial of Vit D and Calcium for Recurrent BPPV

No phase Interventional BPPV Benign Paroxysmal Positional Vertigo Vertigo Vertigo, Peripheral

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: vitamin D +/- calcium, Placebo.
Who it may be relevant to
Registry conditions: BPPV, Benign Paroxysmal Positional Vertigo, Vertigo, Vertigo, Peripheral. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Dietary supplement vitamin D +/- calcium
    vitamin D 1000iU daily +/- calcium 500mg BID daily
  • Other Placebo
    placebo pill x3 daily

Primary outcome measures

  • Recurrence rate of BPPV [Time frame: 1 year]
Secondary outcome measures (7)
  • serum vitamin D levels (25(OH)D3) [Time frame: 1 year]
  • proportion of serum vitamin D normalization [Time frame: 1 year]
  • time to serum vitamin D normalization [Time frame: 1 year]
  • proportion of recurrences [Time frame: 1 year]
  • duration of recurrences [Time frame: 1 year]
  • EQ-5D [Time frame: 1 year]
  • days per year of missed school/work [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 10793337
  • Parnes LS, Agrawal SK, Atlas J. Diagnosis and management of benign paroxysmal positional vertigo (BPPV). CMAJ. 2003 Sep 30;169(7):681-93. PMID 14517129

Identifiers

NCT: NCT05863949 · 20220451-01T

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗