The Role of Vitamin K on Knee Osteoarthritis Outcomes

Boston University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Osteo Arthritis Knee

Treatments: Drug: K1 1000 µg; Drug: Vitamin K1 500 µg; Other: Placebo; Drug: Vitamin K2 (MK-7) 300 µg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06385275

H-44897

K23AR082938 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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55 participants in 4 patient groups, including a placebo group

Vitamin K1 500 µg

Experimental group

Description:

Participants randomized to this arm will take one Vitamin K1 500 µg pill daily for 4 weeks.

Treatment:

Drug: Vitamin K1 500 µg

Vitamin K1 1000 µg

Experimental group

Description:

Participants randomized to this arm will take one Vitamin K1 1000 µg pill daily for 4 weeks.

Treatment:

Drug: K1 1000 µg

Vitamin K2 (MK-7) 300 µg

Experimental group

Description:

Participants randomized to this arm will take one Vitamin K2 (MK-7) 300 µg pill daily for 4 weeks.

Treatment:

Drug: Vitamin K2 (MK-7) 300 µg

Placebo

Placebo Comparator group

Description:

Participants randomized to this arm will take 1 placebo pill daily for 4 weeks.

Treatment:

Other: Placebo