50 Participants Needed

Vitamin K for Osteoarthritis

Recruiting at 1 trial location
SB
Overseen BySarah Booth, PhD

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop using warfarin (a blood thinner), any investigational drugs, and herbal, botanical, or vitamin K supplements before participating.

What data supports the effectiveness of the drug Vitamin K for osteoarthritis?

Research suggests that Vitamin K, particularly Vitamin K2, is beneficial for bone health and may help prevent bone fractures, which is relevant for osteoarthritis patients. Although direct evidence for osteoarthritis is limited, Vitamin K's role in bone metabolism and its potential to reduce fracture risk could indirectly support its use in managing osteoarthritis symptoms.12345

Is Vitamin K safe for humans?

Vitamin K1, especially when given by injection, can cause severe allergic reactions in some people, including breathing problems and heart issues. These reactions are rare but can be serious, so it's important to be cautious with its use.678910

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

Vitamin K is unique because it may help improve bone health by supporting the function of osteocalcin, a protein important for bone strength, and potentially reducing bone loss, which is not a focus of most osteoarthritis treatments. Unlike typical pain relief medications for osteoarthritis, Vitamin K works by influencing bone metabolism and may have additional benefits for bone density.123411

What is the purpose of this trial?

The overall goal of this pilot randomized trial is to obtain necessary prerequisite data to conduct a randomized controlled intervention to test the effect of vitamin K supplementation on knee osteoarthritis progression and related functional decline. To address critical parameters required to design this larger RCT, we will conduct a double-blind, 2-armed, parallel-group intervention study, with a placebo run-in, in which 50 adults with mild to moderate knee OA and low baseline vitamin K status will be randomly assigned to 1 mg phylloquinone/day or matching placebo, and treated for 6 months. Specifically, we will: (1) compare the effects of 1 mg/day phylloquinone vs. placebo on the non-functional circulating form of MGP; (2) estimate rates of recruitment and retention, follow-up rates and reasons for loss to follow-up, response rates to questionnaires, adherence/compliance rates, and potential for site differences; and (3) determine the responsiveness of the Osteoarthritis Research Society International (OARSI)-recommended performance-based tests of physical function in adults with low vitamin K status and mild to moderate knee osteoarthritis. We will also obtain preliminary data on the distribution of MGP genotype at two clinical sites for effect size generation.

Eligibility Criteria

Adults over 50 with mild to moderate knee osteoarthritis and low vitamin K levels can join this study. Participants must be able to swallow capsules, have no severe cognitive impairments or serious medical conditions that would interfere with the trial, not use walking aids or certain supplements, and not plan major relocations or surgeries during the study.

Inclusion Criteria

I can answer questions over the phone.
I have moderate knee arthritis.
I am a man or a woman who has not had a menstrual cycle in the last year.
See 5 more

Exclusion Criteria

Cognitive impairment (based on a Montreal Cognitive Assessment Test score ≤ 17)
Use of other investigational drugs
I am scheduled for knee or hip replacement surgery.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Placebo Run-in

Participants undergo a placebo run-in phase before randomization

2 weeks

Treatment

Participants receive 1 mg/d phylloquinone or placebo for 24 weeks

24 weeks
Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Placebo
  • Vitamin K
Trial Overview The trial is testing if taking 1 mg of Vitamin K daily for six months can slow down knee osteoarthritis progression compared to a placebo. It's a double-blind study where neither participants nor researchers know who gets Vitamin K or placebo until after the results are collected.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vitamin KExperimental Treatment1 Intervention
Participants receive 1 mg/d phylloquinone orally for 24 weeks
Group II: PlaceboPlacebo Group1 Intervention
Participants receive daily placebo matching phylloquinone for 24 weeks

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials
271
Recruited
595,000+

University of North Carolina, Chapel Hill

Collaborator

Trials
1,588
Recruited
4,364,000+

Tufts Medical Center

Collaborator

Trials
264
Recruited
264,000+

Findings from Research

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.
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]
Vitamin K is essential for the carboxylation of proteins like osteocalcin, which is important for bone health, and low intake of vitamin K is linked to a higher risk of osteoporotic fractures.
High doses of vitamin K2 (menatetrenone) have been shown to effectively prevent bone mineral loss and reduce fracture risk in osteoporotic patients, while the benefits of vitamin K1 on bone health remain unclear.
Effects of vitamin K on calcium and bone metabolism.Zittermann, A.[2022]
Dietary intake of vitamin K (phylloquinone) below 100 micrograms daily may not be sufficient for optimal bone health, potentially increasing the risk of osteoporosis and fractures due to undercarboxylation of osteocalcin.
Family physicians should promote adequate vitamin K intake, especially in elderly populations, to help prevent bone loss and fractures, highlighting the need for further research on vitamin K's role in bone metabolism.
Bone health. New role for vitamin K?Ryan-Harshman, M., Aldoori, W.[2018]

References

Associations Between Dietary Intake of Vitamin K and Changes in Symptomatic and Structural Changes in Patients With Knee Osteoarthritis. [2023]
Effects of vitamin K on calcium and bone metabolism. [2022]
Bone health. New role for vitamin K? [2018]
Metabolism and cell biology of vitamin K. [2022]
[Vitamin K2]. [2018]
Cutaneous reactions associated with vitamin K1. [2007]
Efficacy and safety of intravenous phytonadione (vitamin K1) in patients on long-term oral anticoagulant therapy. [2019]
Characterizing the Severe Reactions of Parenteral Vitamin K1. [2020]
Use of oral vitamin K for prevention of late vitamin k deficiency bleeding in neonates when injectable vitamin K is not available. [2012]
10.United Statespubmed.ncbi.nlm.nih.gov
Correction of excessive anticoagulation with low-dose oral vitamin K1. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Vitamin K1 supplementation retards bone loss in postmenopausal women between 50 and 60 years of age. [2019]
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