Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336232
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2006-06-12
Brief Title:
Determinants of Vitamin K Metabolism
Sponsor:
Tufts University
Organization:
Tufts University
Study Overview
Official Title:
Dietary and Non-dietary Components of Vitamin K Metabolism
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 55y will participate in a 62-d metabolic study with a 5d run-in period followed by a 28d dietary vitamin K restriction period 10 ugd and ending with a 28d dietary vitamin K supplementation period 500 ugd 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None