The Role of Vitamin K on Knee Osteoarthritis Outcomes

NCT06385275 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: H-44897K23AR082938
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Keywords

Vitamin K-1; Vitamin K-2; Menaquinone-7 (MK-7); Uncarboxylated matrix Gla protein (ucMGP); Phylloquinone

Outcome Measures

Primary Outcomes (4)

• Change in uncarboxylated matrix Gla protein (ucMGP) levels

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

  Baseline, 4 weeks

• Change in phylloquinone levels

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

  Baseline, 4 weeks

• Sufficient phylloquinone levels

  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.

  Baseline, 4 weeks

• Change in menaquinone-7 (MK-7) levels

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

  Baseline, 4 weeks

Secondary Outcomes (2)

• Study adherence

  4 weeks

• Participant acceptability of intervention

  4 weeks

Study Arms (4)

Vitamin K1 500 µg

EXPERIMENTAL

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

Drug: Vitamin K1 500 µg

Vitamin K1 1000 µg

EXPERIMENTAL

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

Drug: K1 1000 µg

Vitamin K2 (MK-7) 300 µg

EXPERIMENTAL

Participants randomized to this arm will take one Vitamin K2 (MK-7) 300 µg pill daily for 4 weeks.

Drug: Vitamin K2 (MK-7) 300 µg

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Vitamin K1 500 µg DRUG

One pill daily for 4 weeks.

Also known as: Phylloquinone 500 µg

Vitamin K1 500 µg

K1 1000 µg DRUG

One pill daily for 4 weeks.

Also known as: Phylloquinone 1000 µg

Vitamin K1 1000 µg

Vitamin K2 (MK-7) 300 µg DRUG

One pill daily for 4 weeks.

Also known as: Menaquinone 300 µg

Vitamin K2 (MK-7) 300 µg

Placebo OTHER

Placebo pill daily for 4 weeks.

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Boston Medical Center, Rheumatology Clinic

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Interventions

Vitamin K 1; Vitamin K 2; Sugars

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds; Carbohydrates

Study Officials

• Jean Liew, MD MS

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Liew, MD MS

CONTACT

617 358 9655; jwliew@bu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: April 26, 2024
• Study Start: June 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)