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临床试验/NCT05360342
NCT05360342已完成不适用

Incorporation of Vitamin K Into Uremic Lipoproteins

RWTH Aachen University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年3月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Vitamin K content in lipoproteins

研究概览

简要总结

Chronic kidney disease (CKD) patients have an increased cardiovascular risk with corresponding cardiovascular calcifications. CKD patients exhibit a functional vitamin K deficiency. Calcification can be prevented by vitamin K intake. The aim of this study is to investigate the cause for the vitamin K deficiency beyond a diminished dietary vitamin K uptake.

详细描述

This study is a monocentric, 1-armed interventional trial. Participants will be recruited at the University Hospital of the RWTH Aachen.

We will analyse serially collected serum from 10 dialysis patients, after ingestion of a single vitamin K supplement, compared to healthy controls. Lipoprotein fractions will be isolated and the corresponding vitamin K contents will be measured by chromatography.

The vitamin K supplement contains 3 subforms of vitamin K: vitamin K1 (1000µg), menaquinone-4 (1000µg) and menaquinone-7 (200µg).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Vitamin K supplement

Experimental

Administration of a single dose vitamin K

干预措施: Vitamin K supplement (Drug)

结局指标

主要结局

Vitamin K content in lipoproteins

时间窗: 1 year

Assessment of vitamin K incorporation into lipoproteins

次要结局

  • PIVKA-II levels(1 year)

研究者

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

Jürgen Floege

Univ.-Prof. Dr. med.

RWTH Aachen University

研究点 (1)

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