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NCT04450212 · ClinicalTrials.gov registry record · NA
Vitamin K Supplementation Study in Healthy Volunteers (Aim 2B)
A NA study, sponsored by University of Washington.
- Terminated
- Registry status
- NA
- Development phase
- 106
- Enrollment target
NCT04450212: Clinical Trial NA study, sponsored by University of Washington.
NCT04450212 is a NA study that was terminated before completion, run by University of Washington. The registered enrollment target is 106 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04450212, a NA study, was terminated before completion, sponsored by University of Washington.
- TERMINATED
- Registry status
- NA
- Development phase
- 106 participants
- Enrollment target
Study Summary
The overall purpose of this study is to determine how variation in the CYP4F2 gene modulates the synthesis of vitamin K-dependent clotting factors. We propose that the CYP4F2\*3 gene variant increases short- and long-term vitamin K concentrations in the liver by reducing the efficiency of vitamin K metabolism. The investigators will study the effect of vitamin K supplementation on two biomarkers of hepatic vitamin K concentration in groups with defined CYP4F2\*3 genotype. Specifically, the investigators will test for an association between our novel biomarkers of long-term (plasma Factor II proteoforms) and short-term (urinary K-Acid catabolites) hepatic vitamin K concentration and CYP4F2\*3 following a 10-day period of vitamin K supplementation in healthy volunteers.
Primary Outcome
urinary vitamin K-acid/creatinine ratio
Interventions
- GENETIC Phase I, Buccal Swab Collection for DNA Isolation
- DIETARY_SUPPLEMENT Phase II, Vitamin K (Vitacost) Supplementation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2017-08-25 |
| Est. Completion | 2023-07-31 |
| Phase | NA |
Why NCT04450212 stopped before completion
NCT04450212 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Phase I, Buccal Swab Collection for DNA Isolation is the first listed.
NCT04450212 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04450212 about?
NCT04450212 is a clinical study titled "Vitamin K Supplementation Study in Healthy Volunteers (Aim 2B)". The overall purpose of this study is to determine how variation in the CYP4F2 gene modulates the synthesis of vitamin K-dependent clotting factors. We propose that the CYP4F2\*3 gene variant increases short- and long-term vitamin K concentrations in the liver by reducing the efficiency of vitamin K ...
What is the current status of trial NCT04450212?
This trial is currently terminated. It is a NA study. The enrollment target is 106 participants. The study started on 2017-08-25. Estimated completion is 2023-07-31.
What interventions are being tested in trial NCT04450212?
The interventions under investigation include: Phase I, Buccal Swab Collection for DNA Isolation (GENETIC), Phase II, Vitamin K (Vitacost) Supplementation (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04450212?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04450212's enrollment target sits among peer trials
106 830th of 2000 higher than 1,167 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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