MedTrace Logo

Vitamin K Supplementation Study in Healthy Volunteers (Aim 2B)

NCT04450212 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-12-19

No results posted yet for this 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.

Conditions

  • Vitamin K Status

Interventions

GENETIC

Phase I, Buccal Swab Collection for DNA Isolation

Buccal swab will be taken from study participants for DNA isolation.

DIETARY_SUPPLEMENT

Phase II, Vitamin K (Vitacost) Supplementation

1-mg/day phylloquinone (Vitacost; Natures Life K-1 Phylloquinone) for 10 consecutive days. Each dose will be taken in the morning (\~ 8 am), with one half pint of 2% milk to facilitate absorption. Blood and urine samples collection before and during the vitamin K supplementation period.

Sponsors & Collaborators

Principal Investigators

  • Kenneth E Thummel, PhD · University of Washington

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-25
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04450212 on ClinicalTrials.gov