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

NCT02031692 | Completed Phase 4 DMC

• 3 other identifiers: 08-2013-092HI10C20201386-5650-7389-0156
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Paroxysmal Positional Vertigo

Keywords

Benign paroxysmal positional vertigo; Vitamin D; Calcium; Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in serum 25-hydroxy vitamin D level

  Up to 1 year

• Falling frequency

  Up to year

• Fracture frequency

  Up to 1 year

• Quality of life

  Up to 1 year

• Recurrence rate of benign paroxysmal positional vertigo

  Up to 1 year

Study Arms (2)

Vitamin D and calcium supplement

ACTIVE COMPARATOR

Drug: 400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate

Control

NO INTERVENTION

Interventions

400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate DRUG

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.

Also known as: CAVID CHEWABLE TAB, Takeda Pharmaceuticals

Vitamin D and calcium supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Ministry of Food and Drug Safety, Korea: collaborator

Study Sites (1)

Seoul National Universtiy Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (3)

• 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.

  PMID: 23096068 BACKGROUND

• 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.

  PMID: 19307540 BACKGROUND

• Jeong SH, Kim JS. Impaired Calcium Metabolism in Benign Paroxysmal Positional Vertigo: A Topical Review. J Neurol Phys Ther. 2019 Apr;43 Suppl 2:S37-S41. doi: 10.1097/NPT.0000000000000273.

  PMID: 30883492 DERIVED

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Interventions

Cholecalciferol; Calcium; Calcium Carbonate

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Calcium Compounds; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Ji-Soo Kim

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Neurology

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 9, 2014
• Study Start: December 1, 2013
• Primary Completion: May 26, 2017
• Study Completion: June 15, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

KR (1)