Protocol summary

Study aim
Determining the effects of vitamin D in patients with benign paroxysmal positional vertigo
Design
Clinical trial with control and intervention groups, On100 patients, Randomized with a random number table, Not blinded
Settings and conduct
Patients with benign paroxysmal positional vertigo (BPPV) who refer to Baqiyatallah Hospital during the study will be included in the study if they are eligible and will be randomly assigned to two intervention and control groups using a random number table method. Blinding was not performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with confirmed benign paroxysmal positional vertigo, over 18 years of age, vitamin D levels between 30 and 50. Exclusion criteria: Failure to complete the informed consent form, Taking drugs that affect vitamin D metabolism, History of ear surgery, History of Meniere's disease, History of labyrinthitis or vestibular neuritis, Pregnancy or breastfeeding
Intervention groups
In the intervention group, in addition to standard BPPV treatment (Epley maneuver It is a treatment method performed by a physician and involves a series of four head and body movements from sitting to lying down, rolling to the side, and returning to a sitting position.), one 1000-unit vitamin D supplement tablet (Dana Pharma) is prescribed once daily with food until the end of the study (6 months). The dose of vitamin D used in this study is within the daily requirement and completely safe. In the control group , only the Epley therapeutic maneuver is performed, This is the approved standard treatment and it is recommended that patients not take vitamin D supplements until the end of the study.
Main outcome variables
the number of benign paroxysmal positional vertigo (BPPV) attacks, the time interval between BPPV attacks, BPPV attack duration, severity of BPPV attacks, symptoms associated with BPPV

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250207064676N1
Registration date: 2025-04-02, 1404/01/13
Registration timing: prospective

Last update: 2025-04-02, 1404/01/13
Update count: 0
Registration date
2025-04-02, 1404/01/13
Registrant information
Name
Abas Rezaeezade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 4814 2376
Email address
arezaeezade72a91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-21, 1404/02/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of vitamin D in patients with benign paroxysmal positional vertigo (BPPV)
Public title
Studying the effect of vitamin D on benign paroxysmal positional vertigo (BPPV)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with confirmed benign paroxysmal positional vertigo (BPPV) Over 18 years old Serum vitamin D levels should be between 30 and 50
Exclusion criteria:
Failure to complete the informed consent form Taking drugs that affect vitamin D metabolism History of ear surgery History of Meniere's disease History of labyrinthitis or vestibular neuritis Pregnancy or breastfeeding
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple random selection method using a random number table will be used to select individuals. In this way, the researcher first determines the direction of movement in the table and then randomly places her finger on one of the numbers in the table. Then it moves in the direction indicated in the table and records all the numbers. Even numbers will receive the intervention method and odd numbers the control method.
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 Baqiyatallah University of Medical Sciences
Street address
Baqiyatollah University , Molla Sadra Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2025-01-20, 1403/11/01
Ethics committee reference number
IR.BMSU.BAQ.REC.1403.204

Health conditions studied

1

Description of health condition studied
benign paroxysmal positional vertigo(bppv)
ICD-10 code
H81.1
ICD-10 code description
Benign paroxysmal vertigo

Primary outcomes

1

Description
Number of attacks of benign paroxysmal positional vertigo
Timepoint
Evaluation of benign paroxysmal positional vertigo before intervention and one month, three months, and six months after intervention.
Method of measurement
Patient history in the form of a checklist and Hall-Pike maneuver (which is a diagnostic maneuver)

2

Description
Time interval between attacks of benign paroxysmal positional vertigo
Timepoint
Evaluation of benign paroxysmal positional vertigo before intervention and one month, three months, and six months after intervention.
Method of measurement
Patient history in the form of a checklist and Hall-Pike maneuver (which is a diagnostic maneuver)

3

Description
Duration of benign paroxysmal positional vertigo attack
Timepoint
Evaluation of benign paroxysmal positional vertigo before intervention and one month, three months, and six months after intervention.
Method of measurement
Patient history in the form of a checklist and Hall-Pike maneuver (which is a diagnostic maneuver)

4

Description
Severity of benign paroxysmal positional vertigo attacks
Timepoint
Evaluation of benign paroxysmal positional vertigo before intervention and one month, three months, and six months after intervention.
Method of measurement
Patient history in the form of a checklist and Hall-Pike maneuver (which is a diagnostic maneuver)

5

Description
Symptoms associated with benign paroxysmal positional vertigo
Timepoint
Evaluation of benign paroxysmal positional vertigo before intervention and one month, three months, and six months after intervention.
Method of measurement
Patient history in the form of a checklist and Hall-Pike maneuver (which is a diagnostic maneuver)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group : In the intervention group, in addition to standard BPPV treatment (Epley maneuver It is a treatment method performed by a physician and involves a series of four head and body movements from sitting to lying down, rolling to the side, and returning to a sitting position.), one 1000-unit vitamin D supplement tablet (Dana Pharma) is prescribed once daily with food until the end of the study (6 months). The dose of vitamin D used in this study is within the daily requirement and completely safe.
Category
Treatment - Drugs

2

Description
Control group: In this group, only the Epley maneuver is performed, which is the standard treatment, and vitamin D supplementation is not prescribed, and the patient is advised not to take vitamin D until the end of the study.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatullah Hospital
Full name of responsible person
Abas Rezaeezade
Street address
Baqiyatallah Hospital, Molla Sadra Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 4090
Email
arezaeezade72a91@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad Javad Behzadnia
Street address
Baqiyatollah University , Molla Sadra Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 4090
Email
arezaeezade72a91@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Abas Rezaeezade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Block332, Daneshjoo street ,Velayat city ,Babaei Highway
City
Tehran
Province
Tehran
Postal code
1698749511
Phone
+98 83 4814 2376
Email
arezaeezade72a91@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Abas Rezaeezade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Block332, Daneshjoo street, Velayat city, Babaei Highway
City
Tehran
Province
Tehran
Postal code
1698741195
Phone
+98 83 4814 2376
Email
arezaeezade72a91@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Abas Rezaeezade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Block332, Daneshjoo street ,Velayat city, Babaei Highway
City
Tehran
Province
Tehran
Postal code
1698749511
Phone
+98 83 4814 2376
Email
arezaeezade72a91@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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