Vitamin K for Knee Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen byJean Liew, MD MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Boston University

Trial Summary

What is the purpose of 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

This trial is for older adults who have knee osteoarthritis. It's designed to see if different types and doses of vitamin K can help with the condition. To join, participants must meet certain health criteria that aren't specified here.

Inclusion Criteria

My rheumatologist diagnosed me with knee osteoarthritis.

I am 60 years old or older.

English fluency

Exclusion Criteria

I am currently taking blood thinners.

Participant Groups

The study tests two forms of vitamin K (K1 at 1000 µg or 500 µg daily, and K2 as MK-7 at 360 µg daily) against a placebo to find out which one might improve knee OA outcomes. Participants will be randomly assigned to receive one of these options.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Vitamin K2 (MK-7) 300 µgExperimental Treatment1 Intervention

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

Group II: Vitamin K1 500 µgExperimental Treatment1 Intervention

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

Group III: Vitamin K1 1000 µgExperimental Treatment1 Intervention

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

Group IV: PlaceboPlacebo Group1 Intervention

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