An Early Phase 1 interventional study of Combined vitamin D₃ and K₂ supplementation and Vitamin D₃ alone in Benign Paroxismal Positional Vertigo, sponsored by University of Jordan. Completed at 1 site in Jordan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by University of Jordan · Early Phase 1, Interventional, and Treatment
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.
Benign paroxysmal positional vertigo (BPPV) frequently recurs after successful canalith repositioning maneuvers (CRMs). Vitamin D deficiency has been linked to recurrence, but whether adding vitamin K₂ to vitamin D₃ provides additional benefit remains uncertain. We compared 12-month BPPV recurrence among patients receiving combined vitamin D₃ and K₂ (D3K2), vitamin D₃ alone (D3), or CRM alone, and examined whether the association differed by BPPV subtype.
This prospective, nonrandomized cohort study included 404 adults successfully treated with a CRM at a single otolar-yngology center in Amman, Jordan. Treatment was not randomly allocated; participants formed a convenience sample and received D3K2 (n = 212), D3 alone (n = 105), or CRM alone (n = 87). Recurrence was clinically confirmed during 12 months of follow-up. Modified Poisson regression with robust variance estimated risk ratios (RRs), adjusting for age, sex, and BPPV subtype.
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 404 is above the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →University of Jordan is the lead sponsor of 126 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
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.
Drug: Vitamin D₃ alone · Procedure: Canalith repositioning maneuver (CRM) alone
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: Combined vitamin D₃ and K₂ supplementation · Procedure: Canalith repositioning maneuver (CRM) alone
All patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM) alone without receiving any supplementation. 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) 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.
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.
All patients who were diagnosed with benign paroxysmal positional vertigo (BPPV) underwent a canalith repositioning maneuver (CRM)
Recurrence rate of BPPV
The recurrence rate of BPPV within one year after the initial clinical visit
Time frame: 12 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All the following will be shared in the publised paper: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
Supporting information: Study protocol, Sap, Icf
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Jordan