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Metabolic Disorders and Vertigo

Metabolic Disorders and Their Correction in Vertigo and Unsteadiness

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04935970
Enrollment
100
Registered
2021-06-23
Start date
2019-12-10
Completion date
2022-08-31
Last updated
2021-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Paroxysmal Positional Vertigo (BPPV), Central Positional Vertigo, Meniere Disease, Vestibular Migraine, Vestibular Neuritis

Keywords

Benign paroxysmal positional vertigo (BPPV), vestibular neuritis, vestibular migraine, central positional vertigo, Meniere disease, persistent postural-perceptual dizziness (PPPD), vitamin D deficiency, hyperhomocysteinaemia

Brief summary

The purpose of investigation is to assess the levels of metabolic factors (hydroxyvitamin D, homocysteine) between patients with vestibular dysfunction of peripheral origin (BPPV) and central origin (vestibular migraine). Also we will analyse another factors (such as anxiety and depression) and optimize therapeuthical approach accordingly with the data.

Detailed description

Dizziness causes up to 2 to 15% of primary neurological complaints. In some patients who have undergone acute vertigo, postural instability, persistent postural perceptual vertigo (PPPV) develops, while in other similar cases occurs full recovery. So, it is necessary to search for neurophysiological, metabolic and psychophysiological factors and associated premorbid conditions that affect the outcome of neurovestibular compensation. The case-control study will include 2 groups of patients suffering from vertigo of central and peripherial etiology. First group is recruited with patients were diagnosed with peripherial vestibular disorders, such as benign paroxysmal positional vertigo (BPPV), Meniere disease, vestibular neuritis. The proposal number of subjects in the first group is about forty. The second group will consist of forty patients with central vestibular disfunction: vestibular migraine, central positional vertigo etc. The inclusion of patient with persistent postural perceptual dizziness is discussed. Patients will be tested for hydroxyvitamin D and homocysteine in serum using an enzyme-linked immunosorbent assay (ELISA). The perception of the severity of disability was assessed using the Dizziness scale Handicap Inventory (DHI). All patients will undergo psychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'sscale. Statistical analysis was carried out with the Statistical Analysis System (SAS) package. The relationships will be assessed using the chi squared test and logistic regression. The level of significance is set at p \< 0.05. The methods for small samples (Mann-Whitney U ) will be used. It is presumed that differences in vitamin D levels beetween two groups will be considerable.

Interventions

DIAGNOSTIC_TESTdiagnostic blood test

vitamin D deficiency/insufficiency reveal, hyperhomocysteinaemia reveal

neuropsychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'scale.

Sponsors

I.M. Sechenov First Moscow State Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

Inclusion criteria

* Written informed consent of participation in the study; * Age:over 18 years old * complaints of dizziness and insteadiness

Exclusion criteria

* Severe cognitive impairment (dementia) * Severe depression * Syncopal paroxysms * Epileptic seizures * Orthostatic hypotension * Severe arrhythmia, unstable angina pectoris, acute myocardial infarction * Pregnancy 8. Alcoholism, substance abuse and drug addiction * Organic liver and kidney diseases with the development of functional disorders. * Anemia (hemoglobin \<10.5 g / dl for women and \<11.5 g / dl for men) * Active oncological process * Demyelinating and neurodegenerative diseases.

Design outcomes

Primary

MeasureTime frameDescription
vitamin D deficiency/insufficiency revealThrough 1-6 months of diagnosis established.enzyme-linked immunosorbent assay (ELISA).
hyperhomocysteinaemia revealThrough 1-6 months of diagnosis established.enzyme-linked immunosorbent assay (ELISA).

Secondary

MeasureTime frameDescription
correlation between metabolic and neuropsychological disordersthrough study completion, an average of 1 yearneuropsychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'scale.

Countries

Russia

Contacts

Primary ContactLudmila Antonenko, professor
luda6917@yandex.ru89265774431
Backup ContactAnna Bedenko, PhD student
mailanna91@yandex.ru89164989851

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026