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?

This trial explores the optimal form and dose of vitamin K for individuals with knee osteoarthritis (OA). Researchers compare vitamin K1 and vitamin K2 (MK-7) to determine their effectiveness in reducing OA symptoms. Participants will take either one of these vitamins or a placebo daily for four weeks. The trial seeks individuals aged 60 or older who have received a knee OA diagnosis from a rheumatologist and can speak English. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and to measure its effectiveness in an initial, smaller group.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have found that taking high doses of vitamin K1 is safe. However, using it intravenously has been linked to increased risks. This trial focuses on oral administration, which should be much safer.

Research shows that vitamin K2 (MK-7) is well-tolerated by patients. Some studies have shown that even after stopping MK-7, patients did not report significant problems. This suggests that vitamin K2 might be a reliable option without major side effects.

Overall, both forms of vitamin K have demonstrated good safety in studies, making them promising candidates for further research in treating knee osteoarthritis. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Vitamin K1 and Vitamin K2 (MK-7) for knee osteoarthritis because these vitamins offer a unique approach compared to typical treatments like NSAIDs or corticosteroids. Most current therapies primarily focus on reducing inflammation and pain, but Vitamin K might support joint health by playing a role in bone and cartilage maintenance. Vitamin K2, in particular, is known for its potential to enhance calcium regulation, which could provide additional benefits in preserving joint structure. This novel mechanism of action is why these vitamins are being explored as promising alternatives for managing osteoarthritis symptoms.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Research has shown that adequate vitamin K levels are linked to a lower risk of developing knee osteoarthritis (OA) and can help slow its progression. Specifically, low vitamin K levels in the body or diet connect to worsening OA symptoms. This trial studies both types of vitamin K, K1 and K2 (MK-7), for their potential benefits. Participants will receive either Vitamin K1, Vitamin K2 (MK-7) in varying dosages, or a placebo. Vitamin K2, in particular, might increase bone strength and cartilage thickness in knees, which OA often affects. It could also reduce pain and improve joint function. While the optimal dose for these benefits remains unclear, early research suggests that vitamin K could help manage knee OA. ^{2 3 6 7 8}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06385275

The Role of Vitamin K on Knee Osteoarthritis Outcomes Study Overview. The appropriate form and dosing of vitamin K to benefit relevant outcomes in knee osteoarthritis (OA) are not known.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7281970/

The Relationship between Vitamin K and Osteoarthritis The current literature generally agrees that a sufficient level of vitamin K is associated with a lower risk of OA and pathological joint features.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0049017222000816

Genetically predicted vitamin K levels and risk of ... Observational studies have shown that low vitamin K, in serum or dietary intake, is associated with increased incidence and progression of knee OA [3,4]. These ...

4. trials.arthritis.org trials.arthritis.org/trials/NCT06385275

The Role of Vitamin K on Knee Osteoarthritis Outcomes The appropriate form and dosing of vitamin K to benefit relevant outcomes in knee osteoarthritis (OA) are not known. In intervention studies for conditions ...

5. oarsiopenjournal.com oarsiopenjournal.com/article/S2665-9131(21)00035-2/fulltext

The association between vitamin K and medial tibial-femoral ... Our results suggest that decreased vitamin K intake from food may be associated with increased progression of knee OA.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3641753/

Vitamin K Deficiency Is Associated with Incident Knee ... Subclinical vitamin K deficiency was associated with increased risk of developing radiographic knee osteoarthritis and MRI-based cartilage lesions.

7. go.drugbank.com go.drugbank.com/drugs/DB01022

Vitamin K1: Uses, Interactions, Mechanism of Action High doses of vitamin K1 are not associated with toxicity. Intravenous administration has been associated with an increased risk of toxicity. These patients ...

8. withpower.com withpower.com/trial/phase-osteoarthritis-6-2024-7e650

Vitamin K for Knee Osteoarthritis This Phase 1 & 2 medical study run by Boston University is evaluating whether Vitamin K1 and Vitamin K2 (MK-7) will have tolerable side effects & efficacy ...