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The Role of Vitamin K on Knee Osteoarthritis Outcomes

NCT ID: NCT06385275

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-03

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A stratified permuted block randomization will be used to assign 55 participants in a 1:1:1:1 ratio to each intervention arm. A random allocation sequence will be generated by computer in blocks of 4 or 8, stratified by sex and race.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Use of a placebo from Johnson Compounding Pharmacy (Waltham, MA) of similar appearance and taste to the vitamin K supplements will allow for masking of participants, the study PI, and other study team members to the treatment allocation.

Study Groups

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Vitamin K1 500 µg

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

Group Type EXPERIMENTAL

Vitamin K1 500 µg

Intervention Type DRUG

One pill daily for 4 weeks.

Vitamin K1 1000 µg

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

Group Type EXPERIMENTAL

K1 1000 µg

Intervention Type DRUG

One pill daily for 4 weeks.

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.

Group Type EXPERIMENTAL

Vitamin K2 (MK-7) 300 µg

Intervention Type DRUG

One pill daily for 4 weeks.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo pill daily for 4 weeks.

Interventions

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Vitamin K1 500 µg

One pill daily for 4 weeks.

Intervention Type DRUG

K1 1000 µg

One pill daily for 4 weeks.

Intervention Type DRUG

Vitamin K2 (MK-7) 300 µg

One pill daily for 4 weeks.

Intervention Type DRUG

Placebo

Placebo pill daily for 4 weeks.

Intervention Type OTHER

Other Intervention Names

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Phylloquinone 500 µg Phylloquinone 1000 µg Menaquinone 300 µg Sugar pill

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Liew, MD MS

Role: PRINCIPAL_INVESTIGATOR

Boston University Chobanian & Avedisian School of Medicine, Department of Rheumatology

Locations

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Boston Medical Center, Rheumatology Clinic

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jean Liew, MD MS

Role: CONTACT

[email protected]
617 358 9655

Facility Contacts

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Jean Liew, MD MS

Role: primary

[email protected]
617-358-9655

Other Identifiers

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K23AR082938

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-44897

Identifier Type: -

Identifier Source: org_study_id

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