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

November 14, 2017 updated by: Ji-Soo Kim, Seoul National University Bundang Hospital

Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in Benign Paroxysmal Positional Vertigo: A Prospective Multicenter Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1050

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National Universtiy Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Vitamin D and calcium supplement
Drug: 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 Names:
  • CAVID CHEWABLE TAB, Takeda Pharmaceuticals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence frequency of benign paroxysmal positional vertigo
Time Frame: 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.
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in serum 25-hydroxy vitamin D level
Time Frame: 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.
Up to 1 year
Falling frequency
Time Frame: Up to year
To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease falling frequency.
Up to year
Fracture frequency
Time Frame: Up to 1 year
To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease fracture frequency.
Up to 1 year
Quality of life
Time Frame: 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
Up to 1 year
Recurrence rate of benign paroxysmal positional vertigo
Time Frame: 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.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Ministry of Food and Drug Safety, Korea

Investigators

  • Principal Investigator: Ji-Soo Kim, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

May 26, 2017

Study Completion (Actual)

June 15, 2017

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 8, 2014

First Posted (Estimate)

January 9, 2014

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 14, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-2013-092
  • HI10C2020 (Other Grant/Funding Number: Ministry of Health and Welfare)
  • 1386-5650-7389-0156 (Other Identifier: Ministry of Food and Drug Safety, Korea)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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