Osteo Arthritis KneePhase 1/2NCT06385275
The Role of Vitamin K on Knee Osteoarthritis Outcomes
A Phase 1/2 study testing Vitamin K1 500 µg, K1 1000 µg and Vitamin K2 (MK-7) 300 µg in people with Osteo Arthritis Knee, run by Boston University at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Vitamin K1 500 µg, K1 1000 µg and Vitamin K2 (MK-7) 300 µg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2025to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men ≥50 years old
- Women ≥60 years old
- Clinical diagnosis of knee OA by the treating rheumatologist
- English fluency
Who cannot join
- Anticoagulation use (including warfarin, dabigatran, rivaroxaban, apixaban)
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Medical Center, Rheumatology Clinic
Boston, Massachusetts, 02118
About this study
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.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Vitamin K1 500 µg, K1 1000 µg, Vitamin K2 (MK-7) 300 µg, Placebo
- Keywords
- Vitamin K-1, Vitamin K-2, Menaquinone-7 (MK-7), Uncarboxylated matrix Gla protein (ucMGP), Phylloquinone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K1 500 µgDrug
Also called Phylloquinone 500 µg
One pill daily for 4 weeks.
K1 1000 µgDrug
Also called Phylloquinone 1000 µg
One pill daily for 4 weeks.
Vitamin K2 (MK-7) 300 µgDrug
Also called Menaquinone 300 µg
One pill daily for 4 weeks.
PlaceboOther
Also called Sugar pill
Placebo pill daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin K1 500 µg | Experimental | Participants randomized to this arm will take one Vitamin K1 500 µg pill daily for 4 weeks. Receives: Drug: Vitamin K1 500 µg |
| Vitamin K1 1000 µg | Experimental | Participants randomized to this arm will take one Vitamin K1 1000 µg pill daily for 4 weeks. Receives: Drug: K1 1000 µg |
| 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. Receives: Drug: Vitamin K2 (MK-7) 300 µg |
| Placebo | Placebo comparator | Participants randomized to this arm will take 1 placebo pill daily for 4 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in uncarboxylated matrix Gla protein (ucMGP) levels
Plasma ucMGP levels will be measured from blood samples using an enzyme-linked immunoassay (ELISA).
Measured: Baseline, 4 weeks
Change in phylloquinone levels
Plasma phylloquinone will be measured using high-pressure liquid chromatography (HPLC).
Measured: 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.
Measured: Baseline, 4 weeks
Change in menaquinone-7 (MK-7) levels
Menaquinone-7 (MK-7) will be measured from blood samples using HPCL.
Measured: Baseline, 4 weeks
Secondary outcomes (2)
Study adherence
Adherence wil be assessed by analyzing pill counts for each participant.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start3 Jun 2025
- Primary completion8 Sep 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Jean Liew, MD MS, Principal investigator, Boston University Chobanian & Avedisian School of Medicine, Department of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385275
- Sponsor's protocol ID
- H-44897
- Other IDs
- K23AR082938
- Status last verified
- Sep 2026
- First submitted
- 21 Apr 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Vitamin K on Knee Osteoarthritis Outcomes
- ClinicalTrials.gov ID
- NCT06385275
- Acronym / sponsor ID
- H-44897
- Conditions
- Osteo Arthritis Knee
- Keywords
- Vitamin K-1, Vitamin K-2, Menaquinone-7 (MK-7), Uncarboxylated matrix Gla protein (ucMGP), Phylloquinone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 8 Sep 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vitamin K1 500 µg | Experimental | Drug: Vitamin K1 500 µgParticipants randomized to this arm will take one Vitamin K1 500 µg pill daily for 4 weeks. |
| Vitamin K1 1000 µg | Experimental | Drug: K1 1000 µgParticipants randomized to this arm will take one Vitamin K1 1000 µg pill daily for 4 weeks. |
| Vitamin K2 (MK-7) 300 µg | Experimental | Drug: Vitamin K2 (MK-7) 300 µgParticipants randomized to this arm will take one Vitamin K2 (MK-7) 300 µg pill daily for 4 weeks. |
| Placebo | Placebo comparator | Other: PlaceboParticipants randomized to this arm will take 1 placebo pill daily for 4 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men ≥50 years old
- Women ≥60 years old
- Clinical diagnosis of knee OA by the treating rheumatologist
- English fluency
Key exclusion criteria (1 listed)
- Anticoagulation use (including warfarin, dabigatran, rivaroxaban, apixaban)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K1 500 µgAlso: Phylloquinone 500 µgOne pill daily for 4 weeks. | Drug | Vitamin K1 500 µg |
| K1 1000 µgAlso: Phylloquinone 1000 µgOne pill daily for 4 weeks. | Drug | Vitamin K1 1000 µg |
| Vitamin K2 (MK-7) 300 µgAlso: Menaquinone 300 µgOne pill daily for 4 weeks. | Drug | Vitamin K2 (MK-7) 300 µg |
| PlaceboAlso: Sugar pillPlacebo pill daily for 4 weeks. | Other | Placebo |
Primary outcome
Change in uncarboxylated matrix Gla protein (ucMGP) levels
Time frame: Baseline, 4 weeks
Plasma ucMGP levels will be measured from blood samples using an enzyme-linked immunoassay (ELISA).
Change in phylloquinone levels
Time frame: Baseline, 4 weeks
Plasma phylloquinone will be measured using high-pressure liquid chromatography (HPLC).
Sufficient phylloquinone levels
Time frame: 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
Time frame: Baseline, 4 weeks
Menaquinone-7 (MK-7) will be measured from blood samples using HPCL.
2 secondary outcomes
Study adherence
Time frame: 4 weeks
Participant acceptability of intervention
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Liew, MD MS principal investigator
Boston University Chobanian & Avedisian School of Medicine, Department of Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin K1 500 µg, K1 1000 µg and Vitamin K2 (MK-7) 300 µg in people with Osteo Arthritis Knee, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in uncarboxylated matrix Gla protein (ucMGP) levels (time frame: Baseline, 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.