Determinants of Vitamin K Metabolism
Dietary and Non-dietary Components of Vitamin K Metabolism
1 other identifier
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 12, 2006
CompletedFirst Posted
Study publicly available on registry
June 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
May 30, 2016
CompletedNovember 29, 2023
November 1, 2023
3.2 years
June 12, 2006
March 7, 2016
November 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma Phylloquinone
Plasma phylloquinone in response to phylloquinone depletion and repletion
2 months
Study Arms (1)
Diet Intervention
EXPERIMENTAL28 day diet low vitamin K, 28 day diet high vitamin K
Interventions
phylloquinone (vitamin K1) 500 mcg daily in third month
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
Study Sites (1)
Jean Mayer United States Department of Agriculture Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111, United States
Related Publications (7)
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.
PMID: 15722567BACKGROUNDErkkila 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.
PMID: 14767874BACKGROUNDBooth 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.
PMID: 12888638BACKGROUNDBooth 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.
PMID: 11722960BACKGROUNDTraber 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.
PMID: 25739929RESULTTruong 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.
PMID: 22437558RESULTEllis 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.
PMID: 30590596DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sarah Booth, PhD
- Organization
- Tufts University
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah L Booth, PhD
Tufts Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
June 12, 2006
First Posted
June 13, 2006
Study Start
May 1, 2006
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
November 29, 2023
Results First Posted
May 30, 2016
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share