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

Phase 4

Completed

• Conditions: Benign Paroxysmal Positional Vertigo
• Interventions: Drug: 400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate

• Registration Number: NCT02031692
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Primary Completion: 2017-05-26
• Study Completion: 2017-06-15
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-14
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1050

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D and calcium supplement	400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate	-

Primary Outcome Measures

Name	Time	Method
Recurrence frequency of benign paroxysmal positional vertigo	Up to 1 year	The intervention group will receive tablets containing 400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate twice daily (CAVID CHEWABLE TAB, Takeda Pharmaceuticals) for 12 months when the initial serum vitamin D is decreased. The compliance will be determined by the percentage of consumed tablets from the delivered tablets during the follow-up period. Discontinuation of the supplementation due to adverse effects or other reasons will be registered using the telephone interview together with the primary outcome date. Participants in the control group will not have any intervention or placebo. They will not be allowed to take vitamin D or calcium as supplements during the follow-up. The primary outcome measure is the recurrence of BPPV after one year. Data on recurrences will be collected using a monthly telephone interview, and the patients will be asked to visit the clinic whenever they have the symptoms of BPPV. All the recurrences of BPPV will be included.

Secondary Outcome Measures

Name	Time	Method
Changes in serum 25-hydroxy vitamin D level	Up to 1 year	In intervention group, the baseline vitamin D status of participants will be checked. And the level of 25-hydroxyvitamin D level will be rechecked at 2 months from the recruitment and at the end of the follow-up.
Falling frequency	Up to year	To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease falling frequency.
Fracture frequency	Up to 1 year	To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease fracture frequency.
Quality of life	Up to 1 year	To determine the supplementation of the vitamin D and calcium carbonate is related to quality of life using UCLA-dizziness questionnaire
Recurrence rate of benign paroxysmal positional vertigo	Up to 1 year	The intervention group will receive tablets containing 400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate twice daily (CAVID CHEWABLE TAB, Takeda Pharmaceuticals) for 12 months when the initial serum vitamin D is decreased. The compliance will be determined by the percentage of consumed tablets from the delivered tablets during the follow-up period. Discontinuation of the supplementation due to adverse effects or other reasons will be registered using the telephone interview together with the primary outcome date. Participants in the control group will not have any intervention or placebo. They will not be allowed to take vitamin D or calcium as supplements during the follow-up. The primary outcome measure is the recurrence rate of BPPV after one year. Data on recurrences will be collected using a monthly telephone interview, and the patients will be asked to visit the clinic whenever they have the symptoms of BPPV. All the recurrences of BPPV will be included.

Trial Locations

Locations (1)

Seoul National Universtiy Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of