Benign Paroxysmal Positional Vertigo (BPPV)NCT07491965
Association Between Benign Paroxysmal Positional Vertigo and Vitamin D Deficiency .
An observational study of Benign Paroxysmal Positional Vertigo (BPPV), run by Sohag University at 1 site in Egypt.
Trial summary
Association between Benign Paroxysmal Positional Vertigo and Vitamin D deficiency Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo (BPPV)
- What is being tested?
- Vitamin D
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Otolaryngology (ENT) Outpatient Clinic and Audiovestibular unit at Sohag University Hospital, Sohag, Egypt.
Who may be able to join
- • Cases: Adults with a confirmed diagnosis of idiopathic BPPV based on positive Dix-Hallpike maneuver (nystagmus and vertigo lasting <1 minute).
- Controls: Adults attending ENT clinic without history of vertigo or BPPV, confirmed by negative Dix-Hallpike test.
Who cannot join
- Known causes of secondary vertigo (e.g., Meniere's disease, vestibular neuritis, central vertigo).
- Conditions affecting vitamin D metabolism (e.g., chronic kidney disease, malabsorption syndromes, hyperparathyroidism).
- Use of medications interfering with vitamin D levels (e.g., anticonvulsants, glucocorticoids) in the past 3 months.
- Pregnancy or lactation.
- Inability to provide consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association Between Benign Paroxysmal Positional Vertigo and Vitamin D Deficiency ; Sohag University Hospital Experience.
Association between Benign Paroxysmal Positional Vertigo and Vitamin D deficiency
Read the detailed description
Introduction Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular disorder, accounting for approximately 20-30% of vertigo cases in clinical practice. It is characterized by brief episodes of vertigo triggered by changes in head position, often due to dislodged otoconia in the semicircular canals. While canalith repositioning maneuvers like the Epley maneuver are highly effective for treatment, BPPV has a notable recurrence rate of 30-50% within the first year. The etiology remains largely idiopathic, but emerging evidence suggests a potential link to metabolic factors, particularly vitamin D deficiency.
Vitamin D plays a crucial role in calcium homeostasis and bone metabolism, which extends to the inner ear's otolithic apparatus, where calcium carbonate crystals (otoconia) are essential for vestibular function. Deficiency in vitamin D may impair otoconia maintenance, increasing susceptibility to dislodgement and thus BPPV onset or recurrence. Globally, vitamin D deficiency affects up to 1 billion people, with higher prevalence in regions like the Middle East due to limited sun exposure, dietary habits, and cultural factors such as veiling.54cc4a In Egypt, studies report deficiency rates exceeding 70% in the general population, exacerbated by urban lifestyles and pollution in areas like Sohag.
At Sohag University Hospital, a tertiary care center serving a large rural-urban population in Upper Egypt, BPPV constitutes a significant portion of otolaryngology consultations. Preliminary local data indicate a high BPPV incidence among young adults and the elderly, yet the role of vitamin D has not been systematically explored in this setting. This study addresses this gap by examining the association between serum vitamin D levels and BPPV, potentially informing preventive strategies like supplementation in high-risk groups.
Aim of the Work The primary aim is to investigate the association between serum 25-hydroxyvitamin D (25-OH D) levels and the presence of BPPV in patients attending the Otolaryngology Department and Audiovestibular unit at Sohag University Hospital. Secondary aims include identifying potential confounders (e.g., age, sex, comorbidities).
Patients and Methods Study Design: This is a hospital-based case-control study. Setting: Otolaryngology (ENT) Outpatient Clinic and Audiovestibular unit at Sohag University Hospital, Sohag, Egypt.
Study Duration: 5 months (recruitment period: April 2026 to September 2026) from approval of Medical Research Ethics Committee; till September 2026 data analysis: October 2026).
Sample Size: Eighty patients and 80 age- and sex-matched controls will be enrolled (total n=160).
Recruitment: Consecutive sampling. Cases will be identified from patients presenting with vertigo symptoms. Controls will be selected from non-vertigo ENT patients (e.g., those with sinusitis or hearing loss) during the same period to minimize selection bias.
Data Collection:
- Demographic data (age, sex, etc.) via structured questionnaire.
- Clinical history (vertigo duration, recurrence, comorbidities like osteoporosis or diabetes).
- Full ENT examination including Dix Hallpike test to confirm the diagnosis of BPPV and exclude other causes of vertigo.
- Serum 25-OH D levels measured by enzyme-linked immunosorbent assay (ELISA). Ethical Considerations: Approval from the Institutional Review Board (IRB) of Sohag Faculty of Medicine. Informed written consent obtained from all participants. Data confidentiality will be maintained.
Inclusion Criteria
- Cases: Adults with a confirmed diagnosis of idiopathic BPPV based on positive Dix-Hallpike maneuver (nystagmus and vertigo lasting <1 minute).
- Controls: Adults attending ENT clinic without history of vertigo or BPPV, confirmed by negative Dix-Hallpike test.
Exclusion Criteria
- Known causes of secondary vertigo (e.g., Meniere's disease, vestibular neuritis, central vertigo).
- Conditions affecting vitamin D metabolism (e.g., chronic kidney disease, malabsorption syndromes, hyperparathyroidism).
- Use of medications interfering with vitamin D levels (e.g., anticonvulsants, glucocorticoids) in the past 3 months.
- Pregnancy or lactation.
- Inability to provide consent. Methodology This case-control study will compare serum 25-OH D levels between BPPV cases and controls to assess the odds of vitamin D deficiency (<30 ng/mL) in cases.
- Step 1: Diagnosis Confirmation All participants undergo otoscopic examination and Dix-Hallpike testing.
- Step 2: Laboratory Assessment Venous blood sampling for serum 25-OH D and calcium levels. Vitamin D status categorized as: deficiency (<20 ng/mL), insufficiency (20-30 ng/mL), sufficient (>30 ng/mL).
- Step 3: Data Management Data entered into SPSS.
- Step 4: Statistical Analysis Descriptive statistics: Means ± SD for continuous variables (e.g., vitamin D levels); frequencies for categorical (e.g., deficiency prevalence).
Inferential: Independent t-test; chi-square/Fisher's exact for categorical associations. Logistic regression to compute odds ratios (OR) for vitamin D deficiency and BPPV.
- Expected Outcomes: Anticipated higher prevalence of vitamin D deficiency in cases (OR >2), supporting supplementation as a preventive measure.
- Being tested
- Vitamin D
- Keywords
- Vitamin D deficiency, Benign Paroxysmal Positional Vertigo
- Medical subject headings
- Benign Paroxysmal Positional Vertigo, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDiagnostic test
Level of Vitamin D
| Study group | Role | What they receive |
|---|---|---|
| case | Not described Receives: Diagnostic Test: Vitamin D | |
| control | Not described Receives: Diagnostic Test: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Vitamin D in patients with Benign Paroxysmal Positional Vertigo
Measured: From enrollment to 1 months after investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Apr 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Paroxysmal Positional Vertigo (BPPV)Studies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Osama Rashad, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491965
- Sponsor's protocol ID
- Soh-Med-26-3-4MS
- Status last verified
- Jun 2026
- First submitted
- 19 Mar 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Benign Paroxysmal Positional Vertigo and Vitamin D Deficiency ; Sohag University Hospital Experience.
- ClinicalTrials.gov ID
- NCT07491965
- Acronym / sponsor ID
- Soh-Med-26-3-4MS
- Keywords
- Vitamin D deficiency, Benign Paroxysmal Positional Vertigo
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Association between Benign Paroxysmal Positional Vertigo and Vitamin D deficiency
Detailed description
Introduction Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular disorder, accounting for approximately 20-30% of vertigo cases in clinical practice. It is characterized by brief episodes of vertigo triggered by changes in head position, often due to dislodged otoconia in the semicircular canals. While canalith repositioning maneuvers like the Epley maneuver are highly effective for treatment, BPPV has a notable recurrence rate of 30-50% within the first year. The etiology remains largely idiopathic, but emerging evidence suggests a potential link to metabolic factors, particularly vitamin D deficiency.
Vitamin D plays a crucial role in calcium homeostasis and bone metabolism, which extends to the inner ear's otolithic apparatus, where calcium carbonate crystals (otoconia) are essential for vestibular function. Deficiency in vitamin D may impair otoconia maintenance, increasing susceptibility to dislodgement and thus BPPV onset or recurrence. Globally, vitamin D deficiency affects up to 1 billion people, with higher prevalence in regions like the Middle East due to limited sun exposure, dietary habits, and cultural factors such as veiling.54cc4a In Egypt, studies report deficiency rates exceeding 70% in the general population, exacerbated by urban lifestyles and pollution in areas like Sohag.
At Sohag University Hospital, a tertiary care center serving a large rural-urban population in Upper Egypt, BPPV constitutes a significant portion of otolaryngology consultations. Preliminary local data indicate a high BPPV incidence among young adults and the elderly, yet the role of vitamin D has not been systematically explored in this setting. This study addresses this gap by examining the association between serum vitamin D levels and BPPV, potentially informing preventive strategies like supplementation in high-risk groups.
Aim of the Work The primary aim is to investigate the association between serum 25-hydroxyvitamin D (25-OH D) levels and the presence of BPPV in patients attending the Otolaryngology Department and Audiovestibular unit at Sohag University Hospital. Secondary aims include identifying potential confounders (e.g., age, sex, comorbidities).
Patients and Methods Study Design: This is a hospital-based case-control study. Setting: Otolaryngology (ENT) Outpatient Clinic and Audiovestibular unit at Sohag University Hospital, Sohag, Egypt.
Study Duration: 5 months (recruitment period: April 2026 to September 2026) from approval of Medical Research Ethics Committee; till September 2026 data analysis: October 2026).
Sample Size: Eighty patients and 80 age- and sex-matched controls will be enrolled (total n=160).
Recruitment: Consecutive sampling. Cases will be identified from patients presenting with vertigo symptoms. Controls will be selected from non-vertigo ENT patients (e.g., those with sinusitis or hearing loss) during the same period to minimize selection bias.
Data Collection:
- Demographic data (age, sex, etc.) via structured questionnaire.
- Clinical history (vertigo duration, recurrence, comorbidities like osteoporosis or diabetes).
- Full ENT examination including Dix Hallpike test to confirm the diagnosis of BPPV and exclude other causes of vertigo.
- Serum 25-OH D levels measured by enzyme-linked immunosorbent assay (ELISA). Ethical Considerations: Approval from the Institutional Review Board (IRB) of Sohag Faculty of Medicine. Informed written consent obtained from all participants. Data confidentiality will be maintained.
Inclusion Criteria
- Cases: Adults with a confirmed diagnosis of idiopathic BPPV based on positive Dix-Hallpike maneuver (nystagmus and vertigo lasting <1 minute).
- Controls: Adults attending ENT clinic without history of vertigo or BPPV, confirmed by negative Dix-Hallpike test.
Exclusion Criteria
- Known causes of secondary vertigo (e.g., Meniere's disease, vestibular neuritis, central vertigo).
- Conditions affecting vitamin D metabolism (e.g., chronic kidney disease, malabsorption syndromes, hyperparathyroidism).
- Use of medications interfering with vitamin D levels (e.g., anticonvulsants, glucocorticoids) in the past 3 months.
- Pregnancy or lactation.
- Inability to provide consent. Methodology This case-control study will compare serum 25-OH D levels between BPPV cases and controls to assess the odds of vitamin D deficiency (<30 ng/mL) in cases.
- Step 1: Diagnosis Confirmation All participants undergo otoscopic examination and Dix-Hallpike testing.
- Step 2: Laboratory Assessment Venous blood sampling for serum 25-OH D and calcium levels. Vitamin D status categorized as: deficiency (<20 ng/mL), insufficiency (20-30 ng/mL), sufficient (>30 ng/mL).
- Step 3: Data Management Data entered into SPSS.
- Step 4: Statistical Analysis Descriptive statistics: Means ± SD for continuous variables (e.g., vitamin D levels); frequencies for categorical (e.g., deficiency prevalence).
Inferential: Independent t-test; chi-square/Fisher's exact for categorical associations. Logistic regression to compute odds ratios (OR) for vitamin D deficiency and BPPV.
- Expected Outcomes: Anticipated higher prevalence of vitamin D deficiency in cases (OR >2), supporting supplementation as a preventive measure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Diagnostic Test: Vitamin D |
| control | – | Diagnostic Test: Vitamin D |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Otolaryngology (ENT) Outpatient Clinic and Audiovestibular unit at Sohag University Hospital, Sohag, Egypt.
Key inclusion criteria (2 listed)
- • Cases: Adults with a confirmed diagnosis of idiopathic BPPV based on positive Dix-Hallpike maneuver (nystagmus and vertigo lasting <1 minute).
Key exclusion criteria (5 listed)
- Known causes of secondary vertigo (e.g., Meniere's disease, vestibular neuritis, central vertigo).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DLevel of Vitamin D | Diagnostic test | case, control |
Primary outcome
Level of Vitamin D in patients with Benign Paroxysmal Positional Vertigo
Time frame: From enrollment to 1 months after investigation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Paroxysmal Positional Vertigo (BPPV), run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Usama (2001012888469, ahmedurashad2101@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Vitamin D in patients with Benign Paroxysmal Positional Vertigo (time frame: From enrollment to 1 months after investigation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.