The Role of Vitamin K on Knee Osteoarthritis Outcomes

Osteo Arthritis Knee Clinical Trial

Official title:

The Role of Vitamin K on Knee Osteoarthritis Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06385275
• Other study ID #: H-44897
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Boston University
• Contact: Jean Liew, MD MS
• Phone: 617 358 9655
• Email: jwliew[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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; 360µg 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Vitamin K1 500 µg
One pill daily for 4 weeks.
• K1 1000 µg
One pill daily for 4 weeks.
• Vitamin K2 (MK-7) 360 µg
One pill daily for 4 weeks.

Other:
• Placebo
Placebo pill daily for 4 weeks.

Locations

Country	Name	City	State
United States	Boston Medical Center, Rheumatology Clinic	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in phylloquinone levels	Plasma phylloquinone will be measured using high-pressure liquid chromatography (HPLC).	Baseline, 4 weeks
Primary	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
Primary	Change in menaquinone-7 (MK-7) levels	Menaquinone-7 (MK-7) will be measured from blood samples using HPCL.	Baseline, 4 weeks
Secondary	Study adherence	Adherence wil be assessed by analyzing pill counts for each participant.	4 weeks
Secondary	Participant acceptability of intervention	Participants will use a 5 point LIkert scale to rate acceptability of the overall study, the pill tste, gastrointestinal tolerance, burden, and blood collection.	4 weeks