The Role of Vitamin K on Knee Osteoarthritis Outcomes

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston University
Study ID
NCT06385275
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Osteo Arthritis Knee

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vitamin K1 500 µg — DRUG
    One pill daily for 4 weeks.
  • K1 1000 µg — DRUG
    One pill daily for 4 weeks.
  • Vitamin K2 (MK-7) 300 µg — DRUG
    One pill daily for 4 weeks.
  • Placebo — OTHER
    Placebo pill daily for 4 weeks.

Study Details

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.

Key Dates

Start date
Jun 3, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
55 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in uncarboxylated matrix Gla protein (ucMGP) levels [ Time Frame: Baseline, 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Medical Center, Rheumatology ClinicBostonMassachusetts02118
Jean Liew, MD MS
[email protected]
617-358-9655

Find similar trials in Boston, MA

By research site
Boston Medical Center, Rheumatology Clinic· Boston, MA

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