drugset / Trial / NCT07861464
BPPV Recurrence After CRM With & Without Supplementation
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-01-01
- Primary completion
- 2026-07-01
- Completion
- 2026-08-31
Publications
- Background McClure JA. Horizontal canal BPV. J Otolaryngol. 1985 Feb;14(1):30-5.
- Background Epley JM. The canalith repositioning procedure: for treatment of benign paroxysmal positional vertigo. Otolaryngol Head Neck Surg. 1992 Sep;107(3):399-404. doi: 10.1177/019459989210700310.
- Background Epley JM. New dimensions of benign paroxysmal positional vertigo. Otolaryngol Head Neck Surg (1979). 1980 Sep-Oct;88(5):599-605. doi: 10.1177/019459988008800514.
- Background Hall SF, Ruby RR, McClure JA. The mechanics of benign paroxysmal vertigo. J Otolaryngol. 1979 Apr;8(2):151-8.
- Background Schuknecht HF. Cupulolithiasis. Arch Otolaryngol. 1969 Dec;90(6):765-78. doi: 10.1001/archotol.1969.00770030767020. No abstract available.
- Background DIX MR, HALLPIKE CS. The pathology symptomatology and diagnosis of certain common disorders of the vestibular system. Proc R Soc Med. 1952 Jun;45(6):341-54. doi: 10.1177/003591575204500604. No abstract available.
- Background Bárány, E. Diagnose yon krankheitserscheinungen im bereiche des otolithenapparates. Acta Oto-Laryngologica. 1920, 2, 434-437. [DOI: 10.3109/00016482009123103]
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cholecalciferol | Other / unclassified | 4000 iu | — |
| Subject | MK-7 | Unknown | 200 ug | — |