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COMPLETED
NCT07861464
EARLY_PHASE1

BPPV Recurrence After CRM With & Without Supplementation

Sponsor: University of Jordan

View on ClinicalTrials.gov

Summary

Benign paroxysmal positional vertigo (BPPV) may frequently recur even after successful canalith repositioning maneuvers (CRMs). This study investigates whether the addition of vitamin K₂ to vitamin D₃ offers additional benefits for reducing recurrence. It involved 404 adults treated at a single otolaryngology center in Amman, Jordan, divided into three groups: combined D3K2 (n = 212), D3 alone (n = 105), and CRM alone (n = 87). The study used modified Poisson regression to analyze 12-month recurrence rates, adjusting for confounding factors. Recurrence was clinically confirmed during the follow-up period.

Official title: Benign Paroxysmal Positional Vertigo Recurrence After Canalith Re-positioning: A 12-Month Prospective Cohort Comparison of Vitamin D₃ Plus K₂, Vitamin D₃ Alone, and Maneuver Alone.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

404

Start Date

2025-01-01

Completion Date

2026-08-31

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

DRUG

Combined vitamin D₃ and K₂ supplementation

All patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM) and received combined vitamin D₃ and K₂ supplementation. Then they were followed for 12 months, during which recurrent attacks of BPPV were recorded. The combined regimen consisted of cholecalciferol 4000 IU daily and men-aquinone-7 (MK-7) 200 μg daily for 12 months. The MK-7 dose was selected on the basis of prior clinical work showing enhanced carboxylation of vitamin K-dependent proteins.

DRUG

Vitamin D₃ alone

All patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM) and received vitamin D₃ only supplementation (4000 IU daily for 12 months). Then they were followed for 12 months, during which recurrent attacks of BPPV were recorded.

PROCEDURE

Canalith repositioning maneuver (CRM) alone

All patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM)

Locations (1)

University of Jordan

Amman, Jordan