Evaluation of the effect of vitamin D supplementation in reducing vertigo attacks and severity in Meniere’s patients, A Randomized Double-Blind Clinical Trial with Placebo-Controlled

Phase 3

• Conditions: H81.0; meniere disease.; Meniere's disease

• Registration Number: IRCT20210716051908N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified