Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in BPPV
NCT ID: NCT02031692
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1050 participants
INTERVENTIONAL
2013-12-31
2017-06-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Vitamin D and calcium supplement
400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate
The 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.
Control
No interventions assigned to this group
Interventions
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400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate
The 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ministry of Food and Drug Safety, Korea
OTHER_GOV
Seoul National University Bundang Hospital
OTHER
Responsible Party
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Ji-Soo Kim
Professor and Chairman, Department of Neurology
Principal Investigators
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Ji-Soo Kim
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National Universtiy Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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References
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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.
Jeong SH, Choi SH, Kim JY, Koo JW, Kim HJ, Kim JS. Osteopenia and osteoporosis in idiopathic benign positional vertigo. Neurology. 2009 Mar 24;72(12):1069-76. doi: 10.1212/01.wnl.0000345016.33983.e0.
Jeong SH, Kim JS. Impaired Calcium Metabolism in Benign Paroxysmal Positional Vertigo: A Topical Review. J Neurol Phys Ther. 2019 Apr;43 Suppl 2:S37-S41. doi: 10.1097/NPT.0000000000000273.
Other Identifiers
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HI10C2020
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1386-5650-7389-0156
Identifier Type: OTHER
Identifier Source: secondary_id
08-2013-092
Identifier Type: -
Identifier Source: org_study_id