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Determinants of Vitamin K Metabolism
This study is currently recruiting participants.
Verified by Tufts University, February 2008
Sponsored by: Tufts University
Information provided by: Tufts University
ClinicalTrials.gov Identifier: NCT00336232
  Purpose

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.


Condition Intervention
Aging
Osteoporosis
Drug: Vitamin K

MedlinePlus related topics: Osteoporosis
Drug Information available for: Vitamin K Phytonadione Vitamin K1
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Bio-availability Study
Official Title: Dietary and Non-Dietary Components of Vitamin K Metabolism

Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Urinary excretion of VK metabolites at VK depletion and repletion [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Bone turnover markers at VK depletion and repletion [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma triglyceride levels at VK depletion and repletion [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Glucose metabolism measures at VK depletion and repletion [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Mood assessment at VK depletion and repletion [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: May 2006
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Vitamin K
    phylloquinone (vitamin K1) 500 mcg daily in third month
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336232

Contacts
Contact: Jennifer Truong, MD 617-556-3304 vitaminK@tufts.edu

Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University Recruiting
Boston, Massachusetts, United States, 02111
Principal Investigator: Sarah L Booth, PhD            
Sponsors and Collaborators
Tufts University
Investigators
Principal Investigator: Sarah L Booth, PhD Tufts Medical Center
  More Information

Jean Mayer USDA Human Nutrition Research Center on Aging site  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Human Nutrition Research Center on Aging at Tufts University ( Sarah L. Booth )
Study ID Numbers: R01 DK069341
Study First Received: June 12, 2006
Last Updated: February 21, 2008
ClinicalTrials.gov Identifier: NCT00336232  
Health Authority: United States: Federal Government

Keywords provided by Tufts University:
Vitamin K metabolism
Bone health
Metabolism

Study placed in the following topic categories:
Antiplasmin
Musculoskeletal Diseases
Vitamin K
Osteoporosis
Bone Diseases, Metabolic
Vitamin K 1
Bone Diseases

Additional relevant MeSH terms:
Fibrin Modulating Agents
Antifibrinolytic Agents
Coagulants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins
Therapeutic Uses
Physiological Effects of Drugs
Hematologic Agents
Micronutrients
Hemostatics
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009