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

Study Overview
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Brief Summary
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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.

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

Conditions
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Benign Paroxysmal Positional Vertigo

Intervention / Treatment
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* Drug: 400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D and calcium supplement<br> | Drug: 400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate<br>* 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.<br>* Other names: CAVID CHEWABLE TAB, Takeda Pharmaceuticals;|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Falling frequency | To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease falling frequency. | Up to year | 
| Fracture frequency | To determine the supplementation of the vitamin D and calcium carbonate is effective to decrease fracture frequency. | Up to 1 year | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign paroxysmal positional vertigo, Vitamin D, Calcium, Prevention