Vitamin K for Knee Osteoarthritis

Overseen By Jean Liew, MD MS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Boston University

Must not be taking: Anticoagulants

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using anticoagulants (blood thinners like warfarin, dabigatran, rivaroxaban, or apixaban).

Is Vitamin K safe for human use?

Vitamin K2, especially in the form of MK-7, has a history of safe use and is well-tolerated in humans, including pregnant and nursing women and children. However, some people may experience skin reactions to Vitamin K1, especially when given by injection. ^{1 2 3 4 5}

How does the Vitamin K treatment for knee osteoarthritis differ from other treatments?

This treatment is unique because it uses Vitamin K1 and Vitamin K2 (MK-7), which may help improve bone quality and strength by promoting the activation of proteins important for bone health. MK-7, in particular, has a higher bioavailability and longer-lasting effects compared to other forms of Vitamin K, potentially offering more sustained benefits for knee osteoarthritis. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Vitamin K1 and Vitamin K2 (MK-7) for knee osteoarthritis?

Research suggests that Vitamin K2 (MK-7) can help maintain bone health and prevent bone loss, which may be beneficial for knee osteoarthritis. Additionally, studies have shown that dietary vitamin K intake is associated with changes in knee symptoms and structures in patients with knee osteoarthritis. ^{7 10 11 12 13}

Who Is on the Research Team?

Jean Liew, MD MS

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for older adults who have knee osteoarthritis. It's designed to see if different types and doses of vitamin K can help with the condition. To join, participants must meet certain health criteria that aren't specified here.

Inclusion Criteria

My rheumatologist diagnosed me with knee osteoarthritis.

I am 60 years old or older.

English fluency

Exclusion Criteria

I am currently taking blood thinners.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or vitamin K supplementation (Vitamin K1 1000 µg, Vitamin K1 500 µg, or Vitamin K2 (MK-7) 300 µg) daily for 4 weeks

4 weeks

Baseline and end of treatment visits (in-person)

Follow-up

Participants are monitored for changes in biochemical measures and study adherence

4 weeks

End of study visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Vitamin K1
• Vitamin K2 (MK-7)

Trial Overview The study tests two forms of vitamin K (K1 at 1000 µg or 500 µg daily, and K2 as MK-7 at 360 µg daily) against a placebo to find out which one might improve knee OA outcomes. Participants will be randomly assigned to receive one of these options.

How Is the Trial Designed?

Group I: Vitamin K2 (MK-7) 300 µg Experimental Treatment 1 Intervention

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

Group II: Vitamin K1 500 µg Experimental Treatment 1 Intervention

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

Group III: Vitamin K1 1000 µg Experimental Treatment 1 Intervention

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

Group IV: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

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

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

In a study of 259 patients with knee osteoarthritis followed for 2 years, higher dietary vitamin K intake was linked to significant improvements in knee symptoms, as measured by the WOMAC scores.

While vitamin K intake showed promise in reducing symptoms, its effect on knee structures, such as cartilage defects, remains unclear, indicating a need for further clinical trials on vitamin K supplementation for knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations Between Dietary Intake of Vitamin K and Changes in Symptomatic and Structural Changes in Patients With Knee Osteoarthritis. Liao, Z., Chang, J., Zhu, Z., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Associations Between Dietary Intake of Vitamin K and Changes in Symptomatic and Structural Changes in Patients With Knee Osteoarthritis. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Does vitamin D improve symptomatic and structural outcomes in knee osteoarthritis? A systematic review and meta-analysis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Vitamin K2 (menaquinone-7) prevents age-related deterioration of trabecular bone microarchitecture at the tibia in postmenopausal women. [2017]

4. England pubmed.ncbi.nlm.nih.gov

The association between vitamin K and medial tibial-femoral knee osteoarthritis progression: Data from the osteoarthritis initiative. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Three-year low-dose menaquinone-7 supplementation helps decrease bone loss in healthy postmenopausal women. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Comparison of menaquinone-4 and menaquinone-7 bioavailability in healthy women. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of Vitamin K2 (Menaquionones) in Children's Health and Diseases: A Review of the Literature. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Cutaneous hypersensitivity reactions to vitamin K: 2 case reports and a review of the literature. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Anti-arthritis effects of vitamin K(2) (menaquinone-4)--a new potential therapeutic strategy for rheumatoid arthritis. [2007]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Menaquinone-7 as a novel pharmacological therapy in the treatment of rheumatoid arthritis: A clinical study. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Relationship between 25-hydroxy vitamin D and knee osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

MK-7 and Its Effects on Bone Quality and Strength. [2023]

13. Germany pubmed.ncbi.nlm.nih.gov

Distribution of vitamin K2 in subchondral bone in osteoarthritic knee joints. [2021]