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临床试验/NCT04450212
NCT04450212终止不适用

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

University of Washington2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2017年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
106
试验地点
2
主要终点
Short-term Hepatic Vitamin K Status-1

研究概览

简要总结

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.

详细描述

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.

The investigators will recruit, by posted advertisements at UWMC, male and female healthy volunteers. A two-step selection process will be employed. Subjects will self-select by responding to flyers, and contact the research coordinator. The research coordinator will screen them for eligibility over the phone and if eligible, make an appointment for the first study visit. For the first phase, the Research Coordinator will collect a buccal swab of DNA from ~ 200 eligible candidates; the DNA will be tested for absence or presence of the CYP4F2*3 variant allele. The PI and Research Coordinator will review the genotyping results and then select 14 individuals with either a homozygous CYP4F2*3 genotype or a heterozygous CYP4F2*1/*3 genotype, and a demographically matched group of 14 with a homozygous CYP4F2*1 genotype at the diagnostic locus for the supplementation phase of the study. The study coordinator will then contact these subjects by phone for Phase II participation.

Procedures - Phase I, Buccal Swab Collection for DNA Isolation.

Demographic Questionnaire: Self-reported heritage, age, and sex will be collected through a brief demographic questionnaire.

Buccal Swab: We will collect cheek cells with a cotton swab and isolate DNA and test for the CYP4F2*1 and CYP4F2*3 alleles.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Short-term Hepatic Vitamin K Status-1

时间窗: 10-days

urinary vitamin K-acid/creatinine ratio

Long-term Hepatic Vitamin K Status

时间窗: 10-days

plasma factor II carboxylation state

次要结局

  • Short-term Hepatic Vitamin K Status-2(10-days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenneth Thummel

Professor: Pharmaceutics

University of Washington

研究点 (2)

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