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

Benign Paroxysmal Positional Vertigo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031692
• Other study ID #: 08-2013-092
• Secondary ID: HI10C20201386-56
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2014
• Last updated: November 14, 2017
• Start date: December 2013
• Est. completion date: June 15, 2017

Study information

• Verified date: November 2017
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1050
• Est. completion date: June 15, 2017
• Est. primary completion date: May 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• Dizziness
• Recurrence
• Vertigo

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Universtiy Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Ministry of Food and Drug Safety, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 year
Secondary	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.	Up to 1 year
Secondary	Falling frequency	To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease falling frequency.	Up to year
Secondary	Fracture frequency	To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease fracture frequency.	Up to 1 year
Secondary	Quality of life	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
Secondary	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.	Up to 1 year