Osteo Arthritis Knee
Conditions
Keywords
Vitamin K-1, Vitamin K-2, Menaquinone-7 (MK-7), Uncarboxylated matrix Gla protein (ucMGP), Phylloquinone
Brief summary
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.
Interventions
DRUGVitamin K1 500 µg
One pill daily for 4 weeks.
DRUGK1 1000 µg
One pill daily for 4 weeks.
DRUGVitamin K2 (MK-7) 300 µg
One pill daily for 4 weeks.
OTHERPlacebo
Placebo pill daily for 4 weeks.
Sponsors
Boston University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men ≥50 years old * Women ≥60 years old * Clinical diagnosis of knee OA by the treating rheumatologist * English fluency
Exclusion criteria
* Anticoagulation use (including warfarin, dabigatran, rivaroxaban, apixaban)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in uncarboxylated matrix Gla protein (ucMGP) levels | Baseline, 4 weeks | Plasma ucMGP levels will be measured from blood samples using an enzyme-linked immunoassay (ELISA). |
| Change in phylloquinone levels | Baseline, 4 weeks | Plasma phylloquinone will be measured using high-pressure liquid chromatography (HPLC). |
| Sufficient phylloquinone levels | Baseline, 4 weeks | Defined as the the proportion of participants achieving phylloquinone level of \>1.0 nmol/L, which is the level achieved when adequate intakes are met. |
| Change in menaquinone-7 (MK-7) levels | Baseline, 4 weeks | Menaquinone-7 (MK-7) will be measured from blood samples using HPCL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study adherence | 4 weeks | Adherence wil be assessed by analyzing pill counts for each participant. |
| Participant acceptability of intervention | 4 weeks | Participants will use a 5 point LIkert scale to rate acceptability of the overall study, the pill tste, gastrointestinal tolerance, burden, and blood collection. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJean Liew, MD MS
Boston University Chobanian & Avedisian School of Medicine, Department of Rheumatology
Outcome results
None listed