The Role of Vitamin K on Knee Osteoarthritis Outcomes

Phase 1

Recruiting

• Conditions: Osteo Arthritis Knee
• Interventions: Drug: Vitamin K1 500 µg; Drug: K1 1000 µg; Drug: Vitamin K2 (MK-7) 300 µg; Other: Placebo

• Registration Number: NCT06385275
• Lead Sponsor: Boston University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-21
• Study First Submitted QC: 2024-04-24
• Study First Posted: 2024-04-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-27
• Last Update Posted: 2025-04-29
• Study Start: 2025-05
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin K1 500 µg	Vitamin K1 500 µg	Participants randomized to this arm will take one Vitamin K1 500 µg pill daily for 4 weeks.
Vitamin K1 1000 µg	K1 1000 µg	Participants randomized to this arm will take one Vitamin K1 1000 µg pill daily for 4 weeks.
Vitamin K2 (MK-7) 300 µg	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	Placebo	Participants randomized to this arm will take 1 placebo pill daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in uncarboxylated matrix Gla protein (ucMGP) levels	Baseline, 4 weeks	Plasma ucMGP levels will be measured from blood samples using an enzyme-linked immunoassay (ELISA).
Change in phylloquinone levels	Baseline, 4 weeks	Plasma phylloquinone will be measured using high-pressure liquid chromatography (HPLC).
Sufficient phylloquinone levels	Baseline, 4 weeks	Defined as the the proportion of participants achieving phylloquinone level of \>1.0 nmol/L, which is the level achieved when adequate intakes are met.
Change in menaquinone-7 (MK-7) levels	Baseline, 4 weeks	Menaquinone-7 (MK-7) will be measured from blood samples using HPCL.

Secondary Outcome Measures

Name	Time	Method
Study adherence	4 weeks	Adherence wil be assessed by analyzing pill counts for each participant.
Participant acceptability of intervention	4 weeks	Participants will use a 5 point LIkert scale to rate acceptability of the overall study, the pill tste, gastrointestinal tolerance, burden, and blood collection.

Trial Locations

Locations (1)

Boston Medical Center, Rheumatology Clinic; 🇺🇸 Boston, Massachusetts, United States