Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis:

Launched by TUFTS UNIVERSITY · Aug 15, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether taking a daily vitamin K supplement can help improve knee function in adults who have mild to moderate osteoarthritis (OA) and low levels of vitamin K. The study will involve 50 adults aged 50 and older, who will be randomly assigned to receive either 1 mg of vitamin K or a placebo (a pill with no active ingredients) for six months. Participants will be monitored to see how vitamin K affects certain physical functions, as well as to gather important information that will help design a larger study in the future.

To be eligible for this trial, participants must be at least 50 years old, have chronic knee discomfort, and have low vitamin K levels. They should also be able to understand the study and answer questions by phone. However, those with advanced knee OA, certain medical conditions, or who are currently taking specific medications (like blood thinners or other supplements) will not be able to participate. Throughout the study, participants can expect regular check-ins and assessments to track their progress and any changes in their knee function.

Gender

ALL

Eligibility 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