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NCT Number: NCT06385275

The Role of Vitamin K on Knee Osteoarthritis Outcomes

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Boston Medical Center, Rheumatology Clinic

Boston, Massachusetts, 02118, United States

Location status: Recruiting

Location contact

Jean Liew, MD MS

CONTACT

[email protected]

617-358-9655

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men ≥50 years old
  • Women ≥60 years old
  • Clinical diagnosis of knee OA by the treating rheumatologist
  • English fluency

Exclusion criteria

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

Treatment and study plan

Vitamin K1 500 µg

Drug

One pill daily for 4 weeks.

Other names: Phylloquinone 500 µg

K1 1000 µg

Drug

One pill daily for 4 weeks.

Other names: Phylloquinone 1000 µg

Vitamin K2 (MK-7) 300 µg

Drug

One pill daily for 4 weeks.

Other names: Menaquinone 300 µg

Placebo

Other

Placebo pill daily for 4 weeks.

Other names: Sugar pill

Primary outcomes

  1. Change in uncarboxylated matrix Gla protein (ucMGP) levels

    Time frame: Baseline, 4 weeks

    Plasma ucMGP levels will be measured from blood samples using an enzyme-linked immunoassay (ELISA).

  2. Change in phylloquinone levels

    Time frame: Baseline, 4 weeks

    Plasma phylloquinone will be measured using high-pressure liquid chromatography (HPLC).

  3. Sufficient phylloquinone levels

    Time frame: 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.

  4. Change in menaquinone-7 (MK-7) levels

    Time frame: Baseline, 4 weeks

    Menaquinone-7 (MK-7) will be measured from blood samples using HPCL.

Secondary outcomes

  1. Study adherence

    Time frame: 4 weeks

    Adherence wil be assessed by analyzing pill counts for each participant.

  2. Participant acceptability of intervention

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean Liew, MD MS

CONTACT

[email protected]

617 358 9655

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

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

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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