Clinical Trial of Vit D and Calcium for Recurrent BPPV

June 20, 2025 updated by: Darren Tse, Ottawa Hospital Research Institute

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

860

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vitamin D +/- calcium supplementation
patients given Vitamin D 1000iu daily. Also given calcium 500mg BID daily if calcium deficient.
Dietary supplement: vitamin D +/- calcium
vitamin D 1000iU daily +/- calcium 500mg BID daily
Placebo Comparator: Placebo arm
patients given 3 pills of placebo daily.
Other: Placebo
placebo pill x3 daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate of BPPV
Time Frame: 1 year
how many recurrences of BPPV
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum vitamin D levels (25(OH)D3)
Time Frame: 1 year
serum vitamin D levels
1 year
proportion of serum vitamin D normalization
Time Frame: 1 year
do patients normalize
1 year
time to serum vitamin D normalization
Time Frame: 1 year
how long does it take patients to normalize
1 year
proportion of recurrences
Time Frame: 1 year
what proportion of total patients have recurrences
1 year
duration of recurrences
Time Frame: 1 year
how long do recurrences of BPPV last
1 year
EQ-5D
Time Frame: 1 year
quality of life measurement
1 year
days per year of missed school/work
Time Frame: 1 year
days per year of missed school/work
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Darren Tse, MD, Ottawa Hospita Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 20, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220451-01T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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