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

Primary Purpose

Benign Paroxysmal Positional Vertigo

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Benign Paroxysmal Positional Vertigo focused on measuring Benign paroxysmal positional vertigo, Vitamin D, Calcium, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National Universtiy Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Vitamin D and calcium supplement

Control

Arm Description

Outcomes

Primary Outcome Measures

Recurrence frequency of benign paroxysmal positional vertigo
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

Changes in serum 25-hydroxy vitamin D level
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
To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease falling frequency.
Fracture frequency
To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease fracture frequency.
Quality of life
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
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.

Full Information

First Posted
January 8, 2014
Last Updated
November 14, 2017
Sponsor
Seoul National University Bundang Hospital
Collaborators
Ministry of Food and Drug Safety, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02031692
Brief Title
Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in BPPV
Official Title
Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in Benign Paroxysmal Positional Vertigo: A Prospective Multicenter Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 26, 2017 (Actual)
Study Completion Date
June 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Ministry of Food and Drug Safety, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo
Keywords
Benign paroxysmal positional vertigo, Vitamin D, Calcium, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1050 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D and calcium supplement
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate
Other Intervention Name(s)
CAVID CHEWABLE TAB, Takeda Pharmaceuticals
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence frequency of benign paroxysmal positional vertigo
Description
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.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Changes in serum 25-hydroxy vitamin D level
Description
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.
Time Frame
Up to 1 year
Title
Falling frequency
Description
To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease falling frequency.
Time Frame
Up to year
Title
Fracture frequency
Description
To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease fracture frequency.
Time Frame
Up to 1 year
Title
Quality of life
Description
To determine the supplementation of the vitamin D and calcium carbonate is related to quality of life using UCLA-dizziness questionnaire
Time Frame
Up to 1 year
Title
Recurrence rate of benign paroxysmal positional vertigo
Description
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.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji-Soo Kim
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National Universtiy Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23096068
Citation
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.
Results Reference
background
PubMed Identifier
19307540
Citation
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.
Results Reference
background
PubMed Identifier
30883492
Citation
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.
Results Reference
derived

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

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