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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Seoul National University Bundang Hospital
Sponsor:
Collaborator:
Ministry of Food and Drug Safety, Korea
Information provided by (Responsible Party):
Ji-Soo Kim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT02031692
First received: January 8, 2014
Last updated: November 19, 2014
Last verified: November 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Recurrence rate of benign paroxysmal positional vertigo [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Changes in serum 25-hydroxy vitamin D level [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To determine the supplementation of the vitamin D and calcium carbonate is related to quality of life using UCLA-dizziness questionnaire


Estimated Enrollment: 2018
Study Start Date: December 2013
Estimated Primary Completion Date: December 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031692

Contacts
Contact: Ji-Soo Kim 82-31-787-7463 jisookim@snu.ac.kr
Contact: Seong-Hae Jeong 82-42-280-8057 mseaj@hanmail.net

Locations
Korea, Republic of
Seoul National Universtiy Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Ji-Soo Kim    82-31-787-7463    jisookim@snu.ac.kr   
Contact: Hyo-Jung Kim    82-31-787-8149    sasakp@naver.com   
Sub-Investigator: Sun-Young Oh         
Sub-Investigator: Kwang-Dong Choi         
Sub-Investigator: Seo Young Choi         
Sub-Investigator: Seung-Han Lee         
Sub-Investigator: Hyo-Jung Kim         
Sub-Investigator: Jae-Hwan Choi         
Sub-Investigator: Ji Yun Park         
Sub-Investigator: Bong-Hui Kang         
Sub-Investigator: Jae-Il Kim         
Sub-Investigator: Seong-Hae Jeong         
Principal Investigator: Ji-Soo Kim         
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, 1386-5650-7389-0156
Study First Received: January 8, 2014
Last Updated: November 19, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Seoul National University Bundang Hospital:
Benign paroxysmal positional vertigo
Vitamin D
Calcium
Prevention

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

ClinicalTrials.gov processed this record on November 20, 2014