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The Role of Vitamin K on Knee Osteoarthritis Outcomes

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 11% 55 → 49 participants
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Record History

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  1. Primary completion date changed from estimate of Dec 2026 to Sep 8, 2026
    • Eligibility criteria expanded, about 5 words
  2. Enrollment closed, study ongoing
    • Enrollment reduced: 55 → 49 participants
    • Site details revised
    v14
  3. Eligibility criteria expanded, about 5 wordsv13
  4. Re-verified, no change to tracked fieldsv12
  5. Start date changed from estimate of Jun 2025 to Jun 3, 2025v11
Show 9 earlier versionsHide 9 earlier versions
  1. Start date: May 2025 to Jun 2025v10
  2. Start date: Apr 2025 to May 2025v9
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2025 to Apr 2025
    • Site details revised
    v8
  4. Start date: Jan 2025 to Mar 2025v7
  5. Start date: Dec 2024 to Jan 2025v6
  6. Re-verified, no change to tracked fieldsv5
  7. Start date: Sep 2024 to Dec 2024v4
  8. Interventions: K1 1000 µg (Drug), Placebo (Other), Vitamin K1 500 µg (Drug), Vitamin K2 (MK-7) 360 µg (Drug) to K1 1000 µg (Drug), Placebo (Other), Vitamin K1 500 µg (Drug), Vitamin K2 (MK-7) 300 µg (Drug)v3
  9. Phase: Not applicable to Phase 1/2
    • Start date: Jul 2024 to Sep 2024
    • Interventions: K1 1000 µg (Dietary Supplement), Placebo (Other), Vitamin K1 500 µg (Dietary Supplement), Vitamin K2 (MK-7) 360 µg (Dietary Supplement) to K1 1000 µg (Drug), Placebo (Other), Vitamin K1 500 µg (Drug), Vitamin K2 (MK-7) 360 µg (Drug)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The appropriate form and dosing of vitamin K to benefit relevant outcomes in knee osteoarthritis (OA) are not known. In intervention studies for conditions other than knee OA (e.g., prevention of cardiovascular disease), the most commonly used forms and doses include phylloquinone (vitamin K1; 1000µg or 500µg daily) or menaquinone-7 (MK-7 or vitamin K2; 300µg daily). However, whether these doses are adequate to increase vitamin K to levels that ameliorate risk of adverse OA outcomes is not known. Furthermore, although some studies suggest enhanced bioavailability of MK-7 over vitamin K1, as well as extra-hepatic effects, whether this is relevant for an older population with knee OA is not known, The overall goal of this pilot randomized clinical trial (RCT) is to test different subtypes and doses of vitamin K supplementation in older adults with knee OA and to measure changes in relevant biochemical measures.
Trial Details
NCT Number NCT06385275
Lead Sponsor Boston University
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions
(from sponsor)		 Osteo Arthritis Knee
Enrollment 49 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov