Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04450212
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : June 13, 2022
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Kenneth Thummel, University of Washington

Brief 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.

Condition or disease Intervention/treatment Phase
Vitamin K Status Genetic: Phase I, Buccal Swab Collection for DNA Isolation Dietary Supplement: Phase II, Vitamin K (Vitacost) Supplementation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a two-phase study. Healthy adults are screened by genetic analysis in phase I and two sub-groups with specific CYP4F2 genotypes (*1/*1 and *1/*3 or *3/*3) are selected to receive vitamin K supplementation in phase II.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Vitamin K Supplementation Study in Healthy Volunteers (Aim 2B)
Actual Study Start Date : August 25, 2017
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K

Arm Intervention/treatment
Experimental: Phase I, Buccal Swab Collection for DNA Isolation
Approximately 200 healthy volunteers recruited. They complete a brief demographic survey and a undergo one-time buccal swab for collection of cheek cells for DNA analysis.
Genetic: Phase I, Buccal Swab Collection for DNA Isolation
Buccal swab will be taken from study participants for DNA isolation.

Experimental: Phase II, Vitamin K (Vitacost) Supplementation
Subjects from Phase I with a homozygous CYP4F2*1 (n=14) or CYP4F2*3 carriers (n=14) are selected to receive daily vitamin K supplementation, for 10-days. Blood and urine samples are collected sequentially, at baseline, and during the supplementation period.
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.




Primary Outcome Measures :
  1. Short-term Hepatic Vitamin K Status-1 [ Time Frame: 10-days ]
    urinary vitamin K-acid/creatinine ratio

  2. Long-term Hepatic Vitamin K Status [ Time Frame: 10-days ]
    plasma factor II carboxylation state


Secondary Outcome Measures :
  1. Short-term Hepatic Vitamin K Status-2 [ Time Frame: 10-days ]
    Plasma vitamin K acid concentration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Participants will be males or females 18 years and older.
  2. Participants must read and understand English.
  3. Participants must be able to provide informed consent.
  4. Women not currently pregnant or lactating.

Exclusion Criteria:

  1. Participants less than 18 years of age.
  2. Participants unable to read and understand English.
  3. Participants unable to provide informed consent.
  4. Women who are pregnant or lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450212


Contacts
Layout table for location contacts
Contact: Kenneth E Thummel, PhD 206-543-0819 thummel@uw.edu

Locations
Layout table for location information
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Kenneth E. Thummel, PhD    206-543-0819    thummel@uw.edu   
Sponsors and Collaborators
University of Washington
National Institute of General Medical Sciences (NIGMS)
Investigators
Layout table for investigator information
Principal Investigator: Kenneth E Thummel, PhD University of Washington
Layout table for additonal information
Responsible Party: Kenneth Thummel, Professor: Pharmaceutics, University of Washington
ClinicalTrials.gov Identifier: NCT04450212    
Other Study ID Numbers: STUDY00001593
P01GM116691-02S1 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kenneth Thummel, University of Washington:
vitamin K
pharmacogenetics
blood clotting factors
CYP4F2
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamin K
Vitamins
Micronutrients
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants