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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 Osteo Arthritis Knee, sponsored by Boston University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT06385275 is a Phase 1 study of Osteo Arthritis Knee that is actively recruiting participants, run by Boston University. The registered enrollment target is 55 participants, below the 136-participant average among 22 other Osteo Arthritis Knee trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06385275, a Phase 1 study of Osteo Arthritis 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06385275
The ClinicalTrials.gov registry entry for NCT06385275 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 136-participant average among 22 other Osteo Arthritis Knee trials with a reported enrollment target (60% lower). The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Osteo Arthritis Knee appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT06385275 reports 1 study location spanning 1 distinct geographic area - top geographies include 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: Osteo Arthritis 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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