The Role of Vitamin K on Knee Osteoarthritis Outcomes

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorBoston University

About this trial

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

Qualifiers

≥60 years old

Clinical diagnosis of knee OA by the treating rheumatologist

English fluency

Disqualifiers

Anticoagulation use (including warfarin, dabigatran, rivaroxaban, apixaban)

Trial design

Treatments tested in this trial

  • Vitamin K1 500 µg
  • K1 1000 µg
  • Vitamin K2 (MK-7) 300 µg
  • Placebo

Treatment groups

55 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Boston University

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator