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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02031692
First Posted: January 9, 2014
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Food and Drug Safety, Korea
Information provided by (Responsible Party):
Ji-Soo Kim, Seoul National University Bundang Hospital
  Purpose
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.

Condition Intervention Phase
Benign Paroxysmal Positional Vertigo Drug: 400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in Benign Paroxysmal Positional Vertigo: A Prospective Multicenter Randomized Trial

Resource links provided by NLM:


Further study details as provided by Ji-Soo Kim, Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1050
Study Start Date: December 2013
Study Completion Date: June 15, 2017
Primary Completion Date: May 26, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: CAVID CHEWABLE TAB, Takeda Pharmaceuticals
No Intervention: Control

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031692


Locations
Korea, Republic of
Seoul National Universtiy Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Ministry of Food and Drug Safety, Korea
Investigators
Principal Investigator: Ji-Soo Kim Seoul National University Bundang Hospital
  More Information

Publications:
Responsible Party: Ji-Soo Kim, Professor and Chairman, Department of Neurology, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02031692     History of Changes
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 )
First Submitted: January 8, 2014
First Posted: January 9, 2014
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by Ji-Soo Kim, Seoul National University Bundang Hospital:
Benign paroxysmal positional vertigo
Vitamin D
Calcium
Prevention

Additional relevant MeSH terms:
Recurrence
Vertigo
Dizziness
Benign Paroxysmal Positional Vertigo
Disease Attributes
Pathologic Processes
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcium, Dietary
Calcium Carbonate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents