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Determinants of Vitamin K Metabolism

Primary Purpose

Aging, Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin K
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Aging focused on measuring Vitamin K metabolism, Bone health, Metabolism

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - Exclusion Criteria: 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 diabetes smoking hormone therapy in the previous 3 months oral contraceptive use in the previous 3 months; pregnancy strict vegetarian diet

Sites / Locations

  • Jean Mayer United States Department of Agriculture Human Nutrition Research Center on Aging at Tufts University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diet Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Plasma Phylloquinone
Plasma phylloquinone in response to phylloquinone depletion and repletion

Secondary Outcome Measures

Full Information

First Posted
June 12, 2006
Last Updated
October 23, 2017
Sponsor
Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT00336232
Brief Title
Determinants of Vitamin K Metabolism
Official Title
Dietary and Non-dietary Components of Vitamin K Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Osteoporosis
Keywords
Vitamin K metabolism, Bone health, Metabolism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet Intervention
Arm Type
Experimental
Arm Description
28 day diet low vitamin K, 28 day diet high vitamin K
Intervention Type
Drug
Intervention Name(s)
Vitamin K
Other Intervention Name(s)
phylloquinone
Intervention Description
phylloquinone (vitamin K1) 500 mcg daily in third month
Primary Outcome Measure Information:
Title
Plasma Phylloquinone
Description
Plasma phylloquinone in response to phylloquinone depletion and repletion
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Exclusion Criteria: 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 diabetes smoking hormone therapy in the previous 3 months oral contraceptive use in the previous 3 months; pregnancy strict vegetarian diet
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah L Booth, PhD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Mayer United States Department of Agriculture Human Nutrition Research Center on Aging at Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
15722567
Citation
Harrington DJ, Soper R, Edwards C, Savidge GF, Hodges SJ, Shearer MJ. Determination of the urinary aglycone metabolites of vitamin K by HPLC with redox-mode electrochemical detection. J Lipid Res. 2005 May;46(5):1053-60. doi: 10.1194/jlr.D400033-JLR200. Epub 2005 Feb 1.
Results Reference
background
PubMed Identifier
14767874
Citation
Erkkila AT, Lichtenstein AH, Dolnikowski GG, Grusak MA, Jalbert SM, Aquino KA, Peterson JW, Booth SL. Plasma transport of vitamin K in men using deuterium-labeled collard greens. Metabolism. 2004 Feb;53(2):215-21. doi: 10.1016/j.metabol.2003.08.015.
Results Reference
background
PubMed Identifier
12888638
Citation
Booth SL, Martini L, Peterson JW, Saltzman E, Dallal GE, Wood RJ. Dietary phylloquinone depletion and repletion in older women. J Nutr. 2003 Aug;133(8):2565-9. doi: 10.1093/jn/133.8.2565.
Results Reference
background
PubMed Identifier
11722960
Citation
Booth SL, Lichtenstein AH, O'Brien-Morse M, McKeown NM, Wood RJ, Saltzman E, Gundberg CM. Effects of a hydrogenated form of vitamin K on bone formation and resorption. Am J Clin Nutr. 2001 Dec;74(6):783-90. doi: 10.1093/ajcn/74.6.783.
Results Reference
background
PubMed Identifier
25739929
Citation
Traber MG, Leonard SW, Bobe G, Fu X, Saltzman E, Grusak MA, Booth SL. alpha-Tocopherol disappearance rates from plasma depend on lipid concentrations: studies using deuterium-labeled collard greens in younger and older adults. Am J Clin Nutr. 2015 Apr;101(4):752-9. doi: 10.3945/ajcn.114.100966. Epub 2015 Mar 4. Erratum In: Am J Clin Nutr. 2017 Feb;105(2):543.
Results Reference
result
PubMed Identifier
22437558
Citation
Truong JT, Fu X, Saltzman E, Al Rajabi A, Dallal GE, Gundberg CM, Booth SL. Age group and sex do not influence responses of vitamin K biomarkers to changes in dietary vitamin K. J Nutr. 2012 May;142(5):936-41. doi: 10.3945/jn.111.154807. Epub 2012 Mar 21.
Results Reference
result
PubMed Identifier
30590596
Citation
Ellis JL, Fu X, Al Rajabi A, Grusak MA, Shearer MJ, Naumova EN, Saltzman E, Barger K, Booth SL. Plasma Response to Deuterium-Labeled Vitamin K Intake Varies by TG Response, but Not Age or Vitamin K Status, in Older and Younger Adults. J Nutr. 2019 Jan 1;149(1):18-25. doi: 10.1093/jn/nxy216.
Results Reference
derived

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Determinants of Vitamin K Metabolism

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