Benign Paroxysmal Positional Vertigo | Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in BPPV
Benign Paroxysmal Positional Vertigo research study
What is the primary objective of this study?
The purpose of this study is to determine whether the supplementation of vitamin D and calcium prevents recurrences of benign paroxysmal positional vertigo in patients with vitamin D deficiency/insufficiency.
Who is eligible to participate?
Inclusion Criteria: - age 18 years or older - brief episodes of vertigo induced by head motion - a typical positioning nystagmus characteristic of BPPV - no supplementation of vitamin D or calcium at the time of recruitment - informed consent to participate in this study - subject treated by repositioning maneuver Exclusion Criteria: - other identifiable disorders of the central nervous system - supplementation of vitamin D or calcium at the time of recruitment - pregnancy - a history of an allergic reaction, or a medically significant adverse reaction to the investigational product - contraindication to cholecalciferol and calcium carbonate
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Benign Paroxysmal Positional Vertigo
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:400IU cholecalciferol and 500mg of elemental calcium as calcium carbonateThe patients allocated to the intervention group will have a test for serum vitamin D, and receive 800 IU of vitamin D and 1000 mg of calcium as calcium carbonate when the serum vitamin D is decreased. The patients in the control group will be followed up without intervention for one year.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Vitamin D and calcium supplement
Start Date: December 2013
Phase: Phase 4
Primary Outcome: Recurrence frequency of benign paroxysmal positional vertigo
Secondary Outcome: Changes in serum 25-hydroxy vitamin D level
Study sponsors, principal investigator, and references
Principal Investigator: Ji-Soo Kim
Lead Sponsor: Seoul National University Bundang Hospital
Collaborator: Ministry of Food and Drug Safety, Korea
Jeong SH, Kim JS, Shin JW, Kim S, Lee H, Lee AY, Kim JM, Jo H, Song J, Ghim Y. Decreased serum vitamin D in idiopathic benign paroxysmal positional vertigo. J Neurol. 2013 Mar;260(3):832-8. doi: 10.1007/s00415-012-6712-2. Epub 2012 Oct 25.