meniere disease. Meniere's disease
Conditions
Interventions
Intervention 1: Intervention group: In addition to receiving the usual Meniere treatment (betahistine) , Pearl Vitamin D supplement 50,000 units, one per week, after lunch and for 8 weeks will be pres
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with a definitive diagnosis of MD according to the guidelines of the American Academy of Otolaryngology (AAO-HNS) (= 2 episodes of spontaneous vertigo, each lasting at least 20 minutes to 12 hours, along with an audiometric test that Indicates sensorineural hearing loss in the ear involved in low frequency and clinical symptoms such as tinnitus, feeling of fullness of the ear) Age over 18 years Serum levels of 25 (OH) vitD3 less than 30 ng / ml and more than 10 ng / ml
Exclusion criteria
Exclusion criteria: Serum levels of 25 (OH) vitD3 less than 10 ng / ml Consumption of drugs that affect absorption and metabolism of vitamin D (such as: carbamazepine, phenytoin, phenobarbital, rifampin, glucocorticoids, hormonal compounds such as ocp, Bile acid sequestrants, sevelamer, orlistat ...) History of liver disease (chronic liver disease), kidney (chronic renal failure with GFR ? 60 ml / min with persistent increase in parathyroid hormone), uncontrolled hypothyroidism, cystic fibrosis, primary hyperparathyroidism History of neurological disorders History of other autologous diseases Patients with otitis media Having chronic metabolic disorders that may affect vitamin D levels (malabsorption, gastrointestinal surgery, celiac disease, inflammatory bowel disease (IBD)). Pregnant, breastfeeding Reluctance to continue the project, at any time and for any reason during the study Serious side effects during treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Comparison of the average severity of dizziness before and after the intervention in the group consuming vitamin D supplements. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: Visual Analogue Scale, Dizziness Handicap Inventory.;2. Comparison of mean severity of vertigo before and after intervention in the placebo group. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: Visual Analogue Scale, Dizziness Handicap Inventory.;3. Comparison of mean recurrence of vertigo before and after the intervention in the group consuming vitamin D supplements. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: Number of dizziness attacks per month.;Comparison of mean recurrence of vertigo before and after intervention in the placebo group. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: Number of dizziness attacks per month.;Comparison of the mean duration of dizziness before and after the intervention in the group consuming vitamin D supplements. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: The average duration of vertigo attacks per vertigo.;6. Comparison of the mean duration of vertigo before and after the intervention in the placebo group. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: The average duration of vertigo attacks per vertigo.;7. Determining the mean frequency × duration of vertigo in the group consuming vitamin D supplement and comparing it with the placebo group. Timepoint: Beginning of the study (before the intervention) and end of the eig | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the mean severity of tinnitus before and after the intervention in the group taking vitamin D supplements. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: Tinnitus Handicap Inventory.;Comparison of the mean severity of tinnitus before and after the intervention in the placebo group. Timepoint: Beginning of the study (before the intervention) and end of the eighth week (end of the intervention). Method of measurement: Tinnitus Handicap Inventory. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Talebi
Tehran University of Medical Sciences
Outcome results
None listed