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

Phase 3

• Conditions: H81.1; Benign paroxysmal vertigo

• Registration Number: DRKS00011827
• Lead Sponsor: Deutsches Schwindel- und Gleichgewichtszentrum DSGZ und Neurologische Klinik, Klinikum der Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-22
• Study Completion: 2020-05-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 59

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients with relapse(s) of BPPV between visit 2 and final visit (corresponding observation period of 12 months)

Secondary Outcome Measures

Name	Time	Method
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)<br>B. Number of relapses per patient from visit 2 to final visit<br>C. Group analysis: vitamin D<br>1) within reference range at timepoint of study inclusion and Treatment within placebo group<br>2) below reference range at time point of study inclusion and treatment within placebo group<br>3) within reference range at time point of study inclusion and treatment within verum group<br>4) below reference range at time point of study inclusion and treatment within verum group<br>