Vitamin K Supplementation Study in Healthy Volunteers (Aim 2B)
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|ClinicalTrials.gov Identifier: NCT04450212|
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : June 13, 2022
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|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|
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.
- Short-term Hepatic Vitamin K Status-1 [ Time Frame: 10-days ]urinary vitamin K-acid/creatinine ratio
- Long-term Hepatic Vitamin K Status [ Time Frame: 10-days ]plasma factor II carboxylation state
- Short-term Hepatic Vitamin K Status-2 [ Time Frame: 10-days ]Plasma vitamin K acid concentration
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
|Contact: Kenneth E Thummel, PhDemail@example.com|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Kenneth E. Thummel, PhD 206-543-0819 firstname.lastname@example.org|
|Principal Investigator:||Kenneth E Thummel, PhD||University of Washington|