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).
Conditions
Interventions
Trade Name: Dekristol 1000 I.E.
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: CHOLECALCIFEROL
CAS Number: 67-97-0
Other descriptive name: CHOLECALCIFEROL CONCENTRATE (POWDER FORM)
Concentrat
Sponsors
Hospital of the University of Munich
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proof of efficacy of vitamin D to the reduction of the number of patients with one or more relapses of BPPV;Secondary Objective: - Quantification of the limitation due to vertigo (investigation by means of „Dizziness Handicap Inventory“ (DHI) and „Vestibular Disorders Activities of Daily Living Scale“ (VDADL) - Proof of efficacy of vitamin D to the reduction of frequency of relapses of every single patient - Group analysis: vitamin D 1) within reference range at timepoint of study inclusion and treatment within placebo group 2) below reference range at time point of study inclusion and treatment within placebo group 3) within reference range at time point of study inclusion and treatment within verum group 4) below reference range at time point of study inclusion and treatment within verum group ;Primary end point(s): Number of patients with relapse(s) of BPPV between visit 2 and final visit (corresponding observation period of 12 months);Timepoint(s) of evaluation of this end point: - At the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Absolute change of DHI and VDADL measured before (V1), 2 months (V2) and 7 months (V3) after beginning of the therapy and at the end of the treatment period (14 months after beginning of therapy, V4); DHI and VDADL will also be measured at supplementary visits (taking place in case of relapse(s) of BPPV) - Number of relapses per patient from visit 2 to final visit - Group analysis: vitamin D 1) within reference range at timepoint of study inclusion and treatment within placebo group 2) below reference range at time point of study inclusion and treatment within placebo group 3) within reference range at time point of study inclusion and treatment within verum group 4) below reference range at time point of study inclusion and treatment within verum group - Correlation of the levels of vitamin D to the number of patients with relapses and to the number of relapses of the single patient (independent of treatment group) ;Timepoint(s) of evaluation of this end point: - Absolute change of DHI and VDADL measured before (V1), 2 months (V2) and 7 months (V3) after beginning of the therapy and at the end of the treatment period (14 months after beginning of therapy, V4) ); DHI and VDADL will also be measured at supplementary visits (taking place in case of relapse(s) of BPPV) - Administation of the remaining secondary end points at the end of the study | — |
Countries
Germany
Contacts
Public ContactDSGZ Studienzentrale
Hospital of the University of Munich
Outcome results
None listed