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

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)

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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