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Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in BPPV

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Seoul National University

Status and phase

Completed
Phase 4

Conditions

Benign Paroxysmal Positional Vertigo

Treatments

Drug: 400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate

Study type

Interventional

Funder types

Other

Identifiers

NCT02031692
HI10C2020 (Other Grant/Funding Number)
08-2013-092
1386-5650-7389-0156 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

1,050 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,050 participants in 2 patient groups

Vitamin D and calcium supplement
Active Comparator group
Treatment:
Drug: 400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate
Control
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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