The Role of Vitamin K on Knee Osteoarthritis Outcomes
Purpose
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.
Condition
- Osteo Arthritis Knee
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- ≥60 years old - Clinical diagnosis of knee OA by the treating rheumatologist - English fluency
Exclusion Criteria
- Anticoagulation use (including warfarin, dabigatran, rivaroxaban, apixaban)
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- A stratified permuted block randomization will be used to assign 55 participants in a 1:1:1:1 ratio to each intervention arm. A random allocation sequence will be generated by computer in blocks of 4 or 8, stratified by sex and race.
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Vitamin K1 500 µg |
Participants randomized to this arm will take one Vitamin K1 500 µg pill daily for 4 weeks. |
|
|
Experimental Vitamin K1 1000 µg |
Participants randomized to this arm will take one Vitamin K1 1000 µg pill daily for 4 weeks. |
|
|
Experimental Vitamin K2 (MK-7) 300 µg |
Participants randomized to this arm will take one Vitamin K2 (MK-7) 300 µg pill daily for 4 weeks. |
|
|
Placebo Comparator Placebo |
Participants randomized to this arm will take 1 placebo pill daily for 4 weeks. |
|
Recruiting Locations
Boston, Massachusetts 02118
More Details
- Status
- Recruiting
- Sponsor
- Boston University