The purpose of this study was to evaluating the effects of calcium and vitamin D on recorrence rate and severity of benign paroxysmal positional vertigo(BPPV) in Birjand city.
Design
This study is a clinical trial in patients with BPPV.This study is parallel ، nonrandomized ، whithout blindness ، whithout placebo and whithout age limit. Phase 2-3
Settings and conduct
This study is a clinical trial in patients with BBPV in Birjand (Valiasr hospital). Sample size of the study is 86 people including 43 case and 43 control subjects.The duration of this study is 3 months that during of this period the control group will be treated with betahistine 8mg three times a day (for 10 days) and the case group will receive betahistine 8mg three times a day (for 10 days) and calcium 500mg daily (for 3 month) and vitamin D 50000 units perl per week (for 10 weeks). Success rate is measured based on VAS criteria.
Participants/Inclusion and exclusion criteria
All people with BPPV who were diagnosed with Hallpike test were included in the study. People with central lesions such as stroke, Parkinson's disease, history of psychiatric illness and severe impairment were excluded.
Intervention groups
Control group is treated with betahistine and the case group is treated with betahistine and calcium and vitamin D
Main outcome variables
severity of vertigo ، the rate of recorrence of vertgo ، duration of vertigo
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170505033824N1
Registration date:2019-08-02, 1398/05/11
Registration timing:retrospective
Last update:2019-08-02, 1398/05/11
Update count:0
Registration date
2019-08-02, 1398/05/11
Registrant information
Name
Ali Mohammad Pourbagher-Shahri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 5167
Email address
ali.pourbagher@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-30, 1397/10/09
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
2018-12-30, 1397/10/09
Actual recruitment end date
2019-03-15, 1397/12/24
Trial completion date
2019-06-14, 1398/03/24
Scientific title
The effect of taking calcium and vitamin D on the rate af recurrence and severity of benign paroxysmal positional vertigo
Public title
The effect of taking calcium and vitamin D on the rate af recurrence and severity of benign paroxysmal positional vertigo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of peripheral vestibular lesions and proper cognition according to Hallpik test
Exclusion criteria:
Central lesions like stroke, Parkinson's disease, brain trauma according to a neurologist's diagnosis or history of psychiatric diseases or deformities that impair the balance, such as severe spinal deviation or deformity of the lower extremities
Addict and alcoholic people and pregnant women, as well as those who are not willing to participate in the study
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
86
Actual sample size reached:
86
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Birjand - Moallem Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2018-12-28, 1397/10/07
Ethics committee reference number
ir.bums.rec.1397.256
Health conditions studied
1
Description of health condition studied
Benign paroxysmal vertigo
ICD-10 code
H81
ICD-10 code description
Disorders of vestibular function
Primary outcomes
1
Description
severity of vertigo
Timepoint
before intervention - after intervention (3 month)
Method of measurement
VAS criteria
2
Description
duration of vertigo
Timepoint
before intervention - after intervention (3 month)
Method of measurement
VAS criteria
3
Description
rate of recorrence of vertigo
Timepoint
before intervention - after intervention (3 month)
Method of measurement
VAS criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After hallpike test and after training on drug consumption patients will be treated with betahistine 8mg three times a day (for 10 days) and vitamin D 50000 unit (perl per week for 10 weeks) and calcium 500 mg daily (for 3 month)
Category
Treatment - Drugs
2
Description
Control group: After hallpike test and after training on drug consumption patients will be treated with betahistine 8mg three times a day (for 10 days)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-Asr hospital
Full name of responsible person
Dr Mohammad Mousavi
Street address
Birjand،Moallem Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
Mousavi.m903@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Birjand - Moallem Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hadi Motamedi
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Birjand- Moallem Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
Hadi.motamedi92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mohammad Mousavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
Birjand - Moallem Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
Mousavi.m903@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ali Mohammad Pourbagher-Shahri
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Birjand - Moallem Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
ali.pourbagher@bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The entire statistical data from this study can be shared as needed based on the ethics committee's criteria
When the data will become available and for how long
The results of this study, after publishing the results as a paper, will be published and shared
To whom data/document is available
The data from this study will be available to all researchers.
Under which criteria data/document could be used
All academic researchers, in the form of research projects approved by the Ethics Committee, are allowed to access the data and perform the necessary analyzes on the documentation of this research
From where data/document is obtainable
Applicants for obtaining documentation of this study can request information by email with the corresponding author.
What processes are involved for a request to access data/document
Applicants for obtaining documentation of this study can request information by email with the corresponding author.