Benign Paroxysmal Positional Vertigo (BPPV) in Older Patients

NCT04578470 | Unknown Phase 2

• 1 other identifier: BPPV
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Benign Paroxysmal Positional Vertigo (BPPV) is the most common cause of vertigo in older adults (Parham \& Kuchel, 2016). It is caused by dislodged otoconia, which fall from the utricular macula into the semicircular canals causing them to move through the canals with the effect of gravity (Parnes et al., 2003). Treatment of BPPV is primarily with Canalith Repositioning Procedure (CRP) with more than 80% success rates. However, BPPV can recur in 10-20% of the time and in some long-term follow-up studies reporting up to 50% recurrence rates (Fife et al., 2008). Despite BPPV being considered a benign self-limiting condition, it has far reaching physical and psychosocial consequences for the geriatric population such as injuries from falls precipitated by vertiginous attacks and fear of unexpected vertigo leading to restriction of daily activities and functional decline (Balatsouras et al., 2018; Kao et al., 2009). Studies have shown that the 1-year prevalence of individuals with BPPV attacks rises steeply with age, with the cumulative (lifetime) incidence of BPPV reaching almost 10% by the age of 80 (Parham \& Kuchel, 2016). Aging has also been shown to be a primary risk factor for idiopathic BPPV, with events such as prolonged bed rest postulated for being a trigger for BPPV (Parham \& Kuchel, 2016). BPPV is also noted to be underreported in the elderly mainly due to the different manifestations such as less rotatory vertigo and more nonspecific dizziness and instability, with consecutive examinations in geriatric population revealing that 9% of elderly have unrecognized BPPV (Oghalai et al., 2000). Given the increased prevalence and severe implications of BPPV on there is a strong impetus for this study to lower the recurrence of BPPV in this vulnerable older population.

Conditions

Benign Paroxysmal Positional Vertigo

Outcome Measures

Primary Outcomes (2)

• Reduce the recurrence rate of BPPV

  To determine if Vitamin D replacement in those deplete with Vitamin D, combined with dietary interventions, will reduce exacerbations of BPPV and thereby result in functional improvement.

  2 Years

• Delay time to onset of recurrent episodes of BPPV

  To determine if Vitamin D replacement in those deplete with Vitamin D, combined with dietary interventions, will reduce exacerbations of BPPV and thereby result in functional improvement.

  2 Years

Study Arms (3)

Group C

NO INTERVENTION

Patients with replete VitaminD levels (≥30ng/ml) will be serving as a control in group C. Group C will not receive any Vitamin D intervention for the entire 12- month study period but will receive dietary interventions.

Group A

EXPERIMENTAL

Group A will be prescribed Vitamin D supplementation in the form of daily 2000 IU cholecalciferol (two tablets)for 13 weeks, and daily1000 IU cholecalciferol(1tablet) for another 13 weeks and then treatment will be discontinued but dietary interventions will continue across the 12-month study period.

Drug: Vitamin D

Group B

PLACEBO COMPARATOR

Group B will be prescribed placebo of Vitamin D with two tablets daily for 13 weeks then 1 tablet daily for13 weeks then no treatment for 26 weeks but dietary interventions will continue across the 12-month study period.

Drug: Placebo

Interventions

Vitamin D DRUG

Daily 2000 IU cholecalciferol(two tablets) for 13 weeks,and daily 1000 IUcholecalciferol(1 tablet) foranother 13 weeks.

Group A

Placebo DRUG

two tablets daily for 13weeks then 1 tablet daily for13 weeks

Group B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \>/=50 with a history suggestive of idiopathic BPPV, supported by a positive Dix Hallpike test. The study is to be undertaken in older patients hence the age criteria.
• Cognisant or mild neurocognitive impairment (AMT ≥7) to ensure the patient can provide informed consent.
• Both male and female participants will be recruited.

You may not qualify if:

• Patients with identified neurological causes of giddiness
• Patients with major neurocognitive impairment (severe dementia)
• Patients with sarcoidosis, metastatic disease (lymphoma, multiple myeloma), parathyroid disorders.
• Patients with diagnosed osteoporosis or osteopenia who are currently on high dose treatment (50,000 IU/week)
• Patients with significant cervical-spinal radiculopathy, spondylolisthesis, lordosis or kyphosis that will affect ability to carry out CRP
• Patients with disorders causing fat malabsorption (Short gut syndrome, Celiac disease) that will affect dietary absorption of Vitamin D
• Patients with Myasthenia Gravis
• Patients with unexplained hypercalcaemia
• Pregnant women (although this is extremely unlikely in age \>/=50)

Sponsors & Collaborators

• Changi General Hospital: lead

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patient will also undertake a vitamin D and corrected calcium test. Based on the blood test results, the randomisation process and administration of Vitamin D treatment or placebo will be administered by unblinded team while the clinicians and the patients will remain blinded and will not be informed of their allocation within the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 8, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 9, 2020

Record last verified: 2020-10