Trial document




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  DRKS00011827

Trial Description

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Title

Vitamin D in secondary prevention of benign paroxysmal positional vertigo: a prospective, multicenter, randomized, placebo-controlled, double-blind study

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Trial Acronym

VitD@BPPV

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Benign Paroxysmal Positional Vertigo (BPPV) is the most common form of vertigo and approximately half of the patients suffer from relapses within the first 12 months. Due to different factors (age, occurrence with osteoporosis, decreased vitamin D levels) it is supposed that low blood level of vitamin D is supposed to be a risk factor for the appearance of BPPV and its relapses. Therefore, the main objective of this trial is to proof the efficacy of vitamin D in reducing the amount of patients with relapses of BPPV. Within this study, patients receive at random either 1000 IE Vitamin D or placebo (a tablet without active substance) for 14 months.

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Brief Summary in Scientific Language

Benign Paroxysmal Positional Vertigo (BPPV) is the most common form of vertigo and nearly 50 percent of these patients suffer from relapses within the first 12 months. From retrospective studies it is known that patients with BPPV show decreased vitamin D levels. Vitamin D is important for calcium metabolism and formation of otoconia. Furthermore, patients with BPPV often suffer from osteoporosis. All in all, and that the annual incidence of BPPV is markedly increased in older age and females are more affected than males, indicate a link between low levels of vitamin D and occurrence of BPPV. Therefore, the main objective of this trial is to proof the efficacy of vitamin D in reducing the number of patients with one or more relapses of BPPV as well as the number of relapses. Patients receive at random 1000 IE Vitamin D or placebo for 14 months.

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Organizational Data

  •   DRKS00011827
  •   2017/03/22
  •   [---]*
  •   yes
  •   Approved
  •   447-16 fed, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   2015-003395-72 
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Health Condition or Problem studied

  •   H81.1 -  Benign paroxysmal vertigo
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Interventions/Observational Groups

  •   Dekristol (Vitamin D) 1000 IE/day (tablet) for 14 months
  •   Placebo (1 tablet a day for 14 months)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   Yes
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Primary Outcome

Number of patients with relapse(s) of BPPV between visit 2 and final visit (corresponding observation period of 12 months)

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Secondary Outcome

A. 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)
B. Number of relapses per patient from visit 2 to final visit
C. 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/02/24
  •   219
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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 defiency,
Pseudohypoparathyreodism,
Life threatening disease with statistical life expectancy < 12 months,
Former participation in this study or articipation in a clinical trial with intake of an investigational

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Addresses

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    • Deutsches Schwindel- und Gleichgewichtszentrum DSGZ und Neurologische Klinik, Klinikum der Universität München
    • Mr.  Prof.  Michael  Strupp 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Deutsches Schwindel- und Gleichgewichtszentrum DSGZ und Neurologische Klinik, Klinikum der Universität München
    • Mr.  Prof.  Michael  Strupp 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Deutsches Schwindel- und Gleichgewichtszentrum DSGZ und Neurologische Klinik, Klinikum der Universität München
    • Mr.  Prof.  Michael  Strupp 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.