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NCT06385275 · ClinicalTrials.gov registry record · Phase 1
The Role of Vitamin K on Knee Osteoarthritis Outcomes
A Phase 1 study of Osteoarthritis, Knee, sponsored by Boston University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT06385275: Recruiting Phase 1 study of Osteoarthritis, Knee, sponsored by Boston University.
NCT06385275 is a Phase 1 study of Osteoarthritis, Knee that is actively recruiting participants, run by Boston University. The registered enrollment target is 55 participants, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06385275, a Phase 1 study of Osteoarthritis, Knee, is actively recruiting participants, sponsored by Boston University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Plasma ucMGP levels will be measured from blood samples using an enzyme-linked immunoassay (ELISA).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Vitamin K1 500 µg
- DRUG K1 1000 µg
- DRUG Vitamin K2 (MK-7) 300 µg
Study Locations (1)
Massachusetts
- Boston Medical Center, Rheumatology Clinic - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2025-06-03 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT06385275 shows while recruiting
NCT06385275 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT06385275 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06385275 about?
NCT06385275 is a clinical study titled "The Role of Vitamin K on Knee Osteoarthritis Outcomes". 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; 1000µ...
What is the current status of trial NCT06385275?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2025-06-03. Estimated completion is 2026-12.
What conditions does trial NCT06385275 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee.
What interventions are being tested in trial NCT06385275?
The interventions under investigation include: Placebo (OTHER), Vitamin K1 500 µg (DRUG), K1 1000 µg (DRUG), Vitamin K2 (MK-7) 300 µg (DRUG).
Who is sponsoring clinical trial NCT06385275?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06385275 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis, Knee
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06385275's enrollment target sits among peer trials
55 88th of 112 higher than 25 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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