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

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ClinicalTrials.gov Identifier: NCT02031692
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Ministry of Food and Drug Safety, Korea
Information provided by (Responsible Party):
Ji-Soo Kim, Seoul National University Bundang Hospital

Tracking Information
First Submitted Date  ICMJE January 8, 2014
First Posted Date  ICMJE January 9, 2014
Last Update Posted Date November 17, 2017
Study Start Date  ICMJE December 2013
Actual Primary Completion Date May 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 8, 2014)
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.
Change History Complete list of historical versions of study NCT02031692 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2015)
  • 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.
  • Falling frequency [ Time Frame: Up to year ]
    To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease falling frequency.
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2014)
  • 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.
  • Falling frequency [ Time Frame: Up to year ]
    To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease falling frequency.
  • 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.
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in BPPV
Official Title  ICMJE Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in Benign Paroxysmal Positional Vertigo: A Prospective Multicenter Randomized Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Benign Paroxysmal Positional Vertigo
Intervention  ICMJE 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 Name: CAVID CHEWABLE TAB, Takeda Pharmaceuticals
Study Arms  ICMJE
  • Active Comparator: Vitamin D and calcium supplement
    Intervention: Drug: 400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate
  • No Intervention: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2017)
1050
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2014)
2018
Actual Study Completion Date  ICMJE June 15, 2017
Actual Primary Completion Date May 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02031692
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ji-Soo Kim, Seoul National University Bundang Hospital
Study Sponsor  ICMJE Seoul National University Bundang Hospital
Collaborators  ICMJE Ministry of Food and Drug Safety, Korea
Investigators  ICMJE
Principal Investigator: Ji-Soo Kim Seoul National University Bundang Hospital
PRS Account Seoul National University Bundang Hospital
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP