Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23AR082938 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin K1 500 µg | Experimental | Participants randomized to this arm will take one Vitamin K1 500 µg pill daily for 4 weeks. |
|
| Vitamin K1 1000 µg | Experimental | Participants randomized to this arm will take one Vitamin K1 1000 µg pill daily for 4 weeks. |
|
| Vitamin K2 (MK-7) 300 µg | Experimental | Participants randomized to this arm will take one Vitamin K2 (MK-7) 300 µg pill daily for 4 weeks. |
|
| Placebo | Placebo Comparator | Participants randomized to this arm will take 1 placebo pill daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K1 500 µg | Drug | One pill daily for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in uncarboxylated matrix Gla protein (ucMGP) levels | Plasma ucMGP levels will be measured from blood samples using an enzyme-linked immunoassay (ELISA). | Baseline, 4 weeks |
| Change in phylloquinone levels | Plasma phylloquinone will be measured using high-pressure liquid chromatography (HPLC). | Baseline, 4 weeks |
| Sufficient phylloquinone levels | 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. | Baseline, 4 weeks |
| Change in menaquinone-7 (MK-7) levels | Menaquinone-7 (MK-7) will be measured from blood samples using HPCL. | Baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Study adherence | Adherence wil be assessed by analyzing pill counts for each participant. | 4 weeks |
| Participant acceptability of intervention | Participants will use a 5 point LIkert scale to rate acceptability of the overall study, the pill tste, gastrointestinal tolerance, burden, and blood collection. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean Liew, MD MS | Contact | 617 358 9655 | jwliew@bu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jean Liew, MD MS | Boston University Chobanian & Avedisian School of Medicine, Department of Rheumatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center, Rheumatology Clinic | Recruiting | Boston | Massachusetts | 02118 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010837 | Vitamin K 1 |
| D024482 | Vitamin K 2 |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
Not provided
Not provided
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.
Not provided
Not provided
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.
| K1 1000 µg | Drug | One pill daily for 4 weeks. |
|
|
| Vitamin K2 (MK-7) 300 µg | Drug | One pill daily for 4 weeks. |
|
|
| Placebo | Other | Placebo pill daily for 4 weeks. |
|
|
| 4 weeks |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D002241 | Carbohydrates |