Vitamin K for Osteoarthritis
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?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Placebo Run-in
Participants undergo a placebo run-in phase before randomization
Treatment
Participants receive 1 mg/d phylloquinone or placebo for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- Vitamin K
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tufts University
Lead Sponsor
University of North Carolina, Chapel Hill
Collaborator
Tufts Medical Center
Collaborator