跳至主要内容
临床试验/NCT00336232
NCT00336232已完成不适用

Dietary and Non-dietary Components of Vitamin K Metabolism

Tufts University1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2006年5月最近更新:
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
59
试验地点
1
主要终点
Plasma Phylloquinone

研究概览

简要总结

The purpose of this study is to learn how the body responds to different amounts of vitamin K in the diet in order to understand the roles that vitamin K may have in the body. We also need to determine if older adults need more or less vitamin K in their diet compared to younger adults in order to maintain normal body stores of vitamin K.

详细描述

Vitamin K has a role in bone health, but little is known about vitamin K metabolism in aging and in maintenance of bone mass. The limited understanding of vitamin K metabolism impedes the establishment of dietary recommendations for vitamin K, and the interpretation of results from clinical trials on vitamin K supplementation and bone health of women in a narrow age group. This study is the first to assess the role of dietary and other factors that influence the response to vitamin K status and bone turnover to vitamin K depletion and repletion in adults. This study also compares the absorption efficiency and body retention of vitamin K relative to current vitamin K status. Men and women [21 younger (18-40y) and 21 older (55+y)] will participate in a 62-d metabolic study, with a 5d run-in period, followed by a 28d dietary vitamin K restriction period (10 ug/d), and ending with a 28d dietary vitamin K supplementation period (500 ug/d). Coagulation times will be monitored during the dietary restriction period. Serial measurements of vitamin K status markers and of bone turnover markers will show the response of vitamin K to dietary manipulation for both age groups under identically controlled dietary conditions. Deuterium-labeled vitamin K in collards will be used to compare the absorption of vitamin K during a vitamin K-deplete state to that of a vitamin K-replete state. Vitamin K is transported in triglyceride-rich lipoproteins, which may vary among individuals due to differences in adiposity and lipid homeostasis. Therefore, measurement of body composition by Dual Energy X-Ray Absorptiometry (DXA) and plasma lipids will provide insight into the role of lipids in absorption and transport of vitamin K. The findings of this study are critical for the interpretation of the epidemiologic and clinical data used to determine the protective role vitamin K may have in chronic disease prevention.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • kidney, GI, or liver disease requiring treatment
  • prescribed osteoporosis medications in the previous 3 months
  • use of acid reducers more than twice per week
  • blood clotting disorder and/or abnormal clotting time
  • warfarin or anticoagulant use in the previous 12 months
  • hormone therapy in the previous 3 months
  • oral contraceptive use in the previous 3 months; pregnancy
  • strict vegetarian diet

研究组 & 干预措施

Diet Intervention

Experimental

28 day diet low vitamin K, 28 day diet high vitamin K

干预措施: Vitamin K (Drug)

结局指标

主要结局

Plasma Phylloquinone

时间窗: 2 months

Plasma phylloquinone in response to phylloquinone depletion and repletion

次要结局

未报告次要终点

研究者

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

Sarah Booth

Senior Scientist

Tufts University

研究点 (1)

Loading locations...

相似试验

Determinants of Vitamin K Metabolism | 临床试验