Serum Levels of Otolin-1 and Vitamin D in Pre- and Post-treatments of BPPV

August 29, 2023 updated by: Suwicha Isaradisaikul Kaewsiri, Chiang Mai University

Comparative Study for Serum Levels of Otolin-1 and Vitamin D in pre-and Post-treatments of Patients With Benign Paroxysmal Positional Vertigo

BPPV is the most common cause of vertigo. The pathophysiology of BPPV has not been cleared, several studies show that symptoms are caused by the displacement of otoconia from the macula of the utricle into the semicircular canals. These calcium carbonate particles then stimulate non-physiological movement of the endolymph leading to a false sensation of angular acceleration.

Biomarkers represent measurable products of biological processes, thus making an assessment of those processes more practical. Biomarkers in circulation are powerful indicators of normal and pathological biological processes, as well as, responses to pharmacological treatments. The inner ear-inclusive protein that has been published included Otolin-1, Otoconin-90/95, Prestin, Otoancorin, Otogelin, α-tectorin, β-tectorin and Cochlin.

Study Overview

Status

Completed

Conditions

Detailed Description

The posterior canal BPPV is the most common BPPV variant, diagnosed with the Dix-Hallpike test. The lateral canal BPPV is diagnosed with a supine roll test. After treatment of the posterior canal BPPV with a single cycle of the CRP, the rate of negative DHT was 68-80% in the 1st week. Rate of an absence of vertigo and nystagmus on the supine roll test after-treatment of the lateral canal BPPV with the barbecue maneuver plus forced prolonged positioning was 81%.

Biomarkers are often measured in body fluids, they eliminate the need for costly modalities to diagnose and monitor progression. Otolin-1 is a secreted glycoprotein whose messenger RNA (mRNA) expression is restricted to the inner ear, specifically the support cells of the vestibular maculae, semicircular canal cristae, organ of Corti, and marginal cells of the stria vascularis. Otolin-1 blood levels are significantly higher in patients older than 65 years old and increased prevalence of BPPV with age. There were reports of a relationship between vitamin D and otolin-1. Significantly higher serum levels of the otolin-1 protein in patients with BPPV than in healthy controls has been reported. This also confirmed evidence of the otolin-1 as a potential biomarker for BPPV episodes and maybe clinically used to promote better management of BPPV. No data on inner ear biomarkers has been exited in Thailand.

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Chiang Mai, Thailand, 50200
        • Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

BPPV cases in outpatient Ear Nose and Throat (ENT) Clinic at CMU Hospital, Faculty of Medicine, Chiang Mai University during the study period.

Description

Inclusion Criteria:

  1. Age 18 - 80 years
  2. History of brief episodes of positioning vertigo
  3. Positive positioning test; either Dix-Hallpike test or supine roll test in one or both ears
  4. First diagnosis of BPPV or recurrent BPPV

Exclusion Criteria:

  1. Clinical symptoms or sign of other central or peripheral vestibular disorder
  2. Previous history of balance disorders (for controlled group) or Previous history of balance disorders except BPPV (for BPPV group)
  3. Active infection
  4. Active cancer disease
  5. Conditions that may affect the level of otolin-1 such as previous mastoidectomy
  6. Conditions that may affect the level of vitamin D such as cardiovascular disease, diabetes mellitus type2, chronic liver disease, osteoporosis osteomalacia and active symptoms of migraine
  7. Major health conditions; except common chronic conditions e.g. hypertension, hypothyroidism, hypercholesterolemia, and reflux
  8. Major systemic illness, were undergoing active cancer treatment, took prednisone above 10 mg daily, took other immunosuppressive drugs, took any medications for rheumatoid arthritis other than NSAIDs, or had received antibiotics in the previous 6 months
  9. Unable to complete Thai-Dizziness handicap inventory questionnaire
  10. Unable to obtain the blood specimen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of serum otolin-1 and vitamin D
Time Frame: Day 0 and 7±3days after treatment
changes of Level of serum otolin-1 and vitamin D before and after treatment of BPPV
Day 0 and 7±3days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of serum otolin-1 and vitamin D
Time Frame: Day 0 and 7±3days after treatment
Correlation of serum otolin-1 and vitamin D before and after treatment period in BPPV patients
Day 0 and 7±3days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Investigators

  • Principal Investigator: Suwicha Kaewsiri, MD, Department of Otolaryngology , Faculty of Medicine, Chiang Mai University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENT-2563-07658

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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