Study #3060 Vitamin K Osteoarthritis Pilot Trial

Men and women, ages 50 years and older

The purpose of this study is to evaluate whether a Vitamin K supplement (Phytonadione) helps improve lower-extremity function in those with Osteoarthritis compared to a placebo (Microcrystalline Cellulose). Those with osteoarthritis tend to have pain and/or limited function in the area that is affected. Unfortunately, we lack effective treatments to maintain lower extremity function in people with osteoarthritis. Consideration of dietary components and nutrition supplements is a critical area of research.

Major Exclusions:

• Inability to walk
• Planning to relocate or travel extensively during the trial period
• Planned knee or hip arthroplasty during the study period
• Malabsorption disorders such as Chron’s, liver, renal, or celiac disease
• Undergoing cancer treatment

Length of study:            7 months

Residency:                    None

Stipend:                        $25 for screening visit, and up to $750 for the rest of the study for participants who qualify and complete the entire study.

No. of visits:                  4 total visits to the center plus 1 phone call:

• Screening visit: ~3.5 hours
• Enrollment visit: ~2 hours
• Baseline visit: ~3.5 hours
• 3 Month Follow-up Phone call: ~45 min
• 6 Month visit: ~3.5 hours

These visits will involve collection of blood and urine samples, as well as medical information (i.e. height, weight, vitals, etc.), filling out questionnaires, and undergoing physical activity assessments. During your initial screening visit you will also undergo bilateral knee X-rays.

Can I work:   Yes, but those who are employed by Tufts University and qualify to participate in the study, cannot participate during hours in which they are being paid by Tufts University