Boston University
Jean Liew
The appropriate form and dosing of vitamin K to benefit relevant outcomes in knee osteoarthritis (OA) are not known. In intervention studies for conditions other than knee OA (e.g., prevention of cardiovascular disease), the most commonly used forms and doses include phylloquinone (vitamin K1; 1000µg or 500µg daily) or menaquinone-7 (MK-7 or vitamin K2; 300µg daily). However, whether these doses are adequate to increase vitamin K to levels that ameliorate risk of adverse OA outcomes is not known. Furthermore, although some studies suggest enhanced bioavailability of MK-7 over vitamin K1, as well as extra-hepatic effects, whether this is relevant for an older population with knee OA is not known, The overall goal of this pilot randomized clinical trial (RCT) is to test different subtypes and doses of vitamin K supplementation in older adults with knee OA and to measure changes in relevant biochemical measures.
Osteo Arthritis Knee
Vitamin K1 500 µg
K1 1000 µg
Vitamin K2 (MK-7) 300 µg
Placebo
PHASE1
PHASE2
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 55 participants |
| Masking : | TRIPLE |
| Masking Description : | Use of a placebo from Johnson Compounding Pharmacy (Waltham, MA) of similar appearance and taste to the vitamin K supplements will allow for masking of participants, the study PI, and other study team members to the treatment allocation. |
| Primary Purpose : | TREATMENT |
| Official Title : | The Role of Vitamin K on Knee Osteoarthritis Outcomes |
| Actual Study Start Date : | 2024-09 |
| Estimated Primary Completion Date : | 2026-12 |
| Estimated Study Completion Date : | 2026-12 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 60 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Boston Medical Center, Rheumatology Clinic
Boston, Massachusetts, United States, 02118