Clinical Trial of Vit D and Calcium for Recurrent BPPV

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • vitamin D +/- calcium

    Dietary supplement

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

  • Placebo

    Other intervention

    placebo pill x3 daily

Treatment groups

860 Participants
are divided into 2 treatment groups
Group A: vitamin D +/- calcium supplementationExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recurrence rate of BPPV

how many recurrences of BPPV

Time frame
1 year

Secondary outcomes

1

serum vitamin D levels (25(OH)D3)

serum vitamin D levels

Time frame
1 year
2

proportion of serum vitamin D normalization

do patients normalize

Time frame
1 year
3

time to serum vitamin D normalization

how long does it take patients to normalize

Time frame
1 year
4

proportion of recurrences

what proportion of total patients have recurrences

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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