Vitamin K's effects on knee function in adults with osteoarthritis
Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis: A Randomized Controlled Pilot Trial
This study is testing if taking vitamin K can help improve knee function in adults over 50 with mild to moderate osteoarthritis and low vitamin K levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Tufts University Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05505552 on ClinicalTrials.gov |
What this trial studies
This pilot randomized trial aims to gather essential data for a larger study on the impact of vitamin K supplementation on knee osteoarthritis progression and functional decline. It will involve 50 adults aged 50 and older with mild to moderate knee osteoarthritis and low vitamin K levels, who will be randomly assigned to receive either 1 mg of phylloquinone (vitamin K) or a placebo daily for six months. The study will assess various outcomes, including the effects on a specific protein related to osteoarthritis and the feasibility of conducting a larger randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 and older with mild to moderate knee osteoarthritis and low baseline vitamin K status.
Not a fit: Patients with severe osteoarthritis (KL grade 4), cognitive impairments, or serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how vitamin K supplementation may improve knee function and slow the progression of osteoarthritis.
How similar studies have performed: While this approach is novel in the context of knee osteoarthritis, similar studies on vitamin K's effects in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 50 years * Male or post-menopausal female (no menses in the last year) * Plasma phylloquinone \<1.0 nmol/L * Chronic knee discomfort based on affirmative response to the question "During the past 12 months, have you had pain, aching, or stiffness in or around your knee(s) on most days for at least one month?" * Kellgren-Lawrence (KL) grade 2-3 in at least one knee * Ability to understand study procedures and to comply with them for the entire length of the study * Ability to answer questions by phone * Ability to swallow capsules Exclusion Criteria: * KL grade 4 in at least one knee * Inability to walk * Cognitive impairment (based on a Montreal Cognitive Assessment Test score ≤ 17) * Widespread pain * Malabsorption disorders (e.g. advance liver disease, stage 4 or 5 chronic renal disease, Crohn's disease, celiac sprue) * Serious medical conditions or impairments that, in the view of the investigator, would obstruct study participation * Plan to permanently relocate from the greater Boston, MA or Chapel Hill NC areas during the trial period * Planned knee or hip arthroplasty during the study period * Undergoing cancer treatment * \< 50 years old * Circulating phylloquinone ≥ 1.0 nmol/L * Warfarin (Jantoven) use * Use of other investigational drugs * Use of herbal, botanical or vitamin K supplements * Use of assistive walking devices
Where this trial is running
Boston, Massachusetts and 1 other locations
- Tufts University — Boston, Massachusetts, United States (Recruiting)
- University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Sarah Booth, PhD
- Email: sarah.booth@tufts.edu
- Phone: 617 556 3231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.