The Role of Vitamin K on Knee Osteoarthritis Outcomes

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• ≥60 years old

• Clinical diagnosis of knee OA by the treating rheumatologist

• English fluency

Locations
United States
Massachusetts
Boston Medical Center, Rheumatology Clinic
RECRUITING
Boston
Contact Information
Primary
Jean Liew, MD MS
jwliew@bu.edu
617 358 9655
Time Frame
Start Date: 2025-06-03
Estimated Completion Date: 2026-12
Participants
Target number of participants: 55
Treatments
Experimental: Vitamin K1 500 µg
Participants randomized to this arm will take one Vitamin K1 500 µg pill daily for 4 weeks.
Experimental: Vitamin K1 1000 µg
Participants randomized to this arm will take one Vitamin K1 1000 µg pill daily for 4 weeks.
Experimental: Vitamin K2 (MK-7) 300 µg
Participants randomized to this arm will take one Vitamin K2 (MK-7) 300 µg pill daily for 4 weeks.
Placebo_comparator: Placebo
Participants randomized to this arm will take 1 placebo pill daily for 4 weeks.
Related Therapeutic Areas
Sponsors
Leads: Boston University
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This content was sourced from clinicaltrials.gov