Health TrialsbyHealthPanel

The Role of Vitamin K on Knee Osteoarthritis Outcomes

ConditionOsteo Arthritis Knee
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorBoston University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥60 years old

Clinical diagnosis of knee OA by the treating rheumatologist

English fluency

Disqualifiers

Anticoagulation use (including warfarin, dabigatran, rivaroxaban, apixaban)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin K1 500 µg

    Drug

    One pill daily for 4 weeks.

  • 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 intervention

    Placebo pill daily for 4 weeks.

Treatment groups

55 Participants
are divided into 4 treatment groups
Group A: Vitamin K1 500 µgExperimental treatment 1 intervention
Group B: Vitamin K1 1000 µgExperimental treatment 1 intervention
Group C: Vitamin K2 (MK-7) 300 µgExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in uncarboxylated matrix Gla protein (ucMGP) levels

Plasma ucMGP levels will be measured from blood samples using an enzyme-linked immunoassay (ELISA).

Time frame
Baseline, 4 weeks
2

Change in phylloquinone levels

Plasma phylloquinone will be measured using high-pressure liquid chromatography (HPLC).

Time frame
Baseline, 4 weeks
3

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.

Time frame
Baseline, 4 weeks
4

Change in menaquinone-7 (MK-7) levels

Menaquinone-7 (MK-7) will be measured from blood samples using HPCL.

Time frame
Baseline, 4 weeks

Secondary outcomes

1

Study adherence

Adherence wil be assessed by analyzing pill counts for each participant.

Time frame
4 weeks
2

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.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston University

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Source ClinicalTrials.gov
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