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Recruiting Phase 1, Phase 2 NCT06385275

The Role of Vitamin K on Knee Osteoarthritis Outcomes

Trial Parameters

Condition Osteo Arthritis Knee
Sponsor Boston University
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 55
Sex ALL
Min Age 60 Years
Max Age N/A
Start Date 2025-06-03
Completion 2026-12
Interventions
Vitamin K1 500 µgK1 1000 µgVitamin K2 (MK-7) 300 µg

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * ≥60 years old * Clinical diagnosis of knee OA by the treating rheumatologist * English fluency Exclusion Criteria: * Anticoagulation use (including warfarin, dabigatran, rivaroxaban, apixaban)

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