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Vitamin D in secondary prevention of BPPV

Phase 1
Conditions
The main symptoms of Benign Paroxysmal Positional Vertigo (BPPV) are brief, in part strong attacks of rotatory vertigo lasting seconds. These attacks can be provoked by reclination of the head or turning of the head/the body toward the affected ear. The pathophysiology of BPPV is related to a displacement of the otoconia toward the semicircular canals, which may remain floating in the endolymph of the semicircular canal (canalolithiasis) or adhere to the cupula (cupulithiasis).
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Registration Number
EUCTR2015-003395-72-DE
Lead Sponsor
Hospital of the University of Munich
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
219
Inclusion Criteria

- Written informed consent to participation in the study
- Age = 18 years
- Patients with BPPV of the posterior, horizontal or anterior semicircular canal (confirmed by diagnostic maneuvers) of different etiologies (idiopathic, traumatic, other vestibular diseases)
- The ability to follow study instructions and likely to attend and complete all visit

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 59
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

Exclusion Criteria

- Osteoporosis
- Hyper-/Hypocalcemia
- Hyper-/Hypophosphatemia
- Hypercalcuria
- Uro-/Nephrolithiasis in medical history
- Intake of vitamin D-metabolites/-analogues
- Intake of cardiac glycosides
- Sarkoidosis
- Active or intended pregnancy
- Hereditary fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency, congenital galactose intolerance, congenital lactase deficiency
- Pseudohypoparathyreodism
- Life threatening disease with statistical life expectancy < 12 months
- Former participation in this study or participation in a clinical trial with intake of an investigational drug within the last 30 days before participation in this study

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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