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Sponsored by: |
Tufts University |
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Information provided by: | Tufts University |
ClinicalTrials.gov Identifier: | NCT00336232 |
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 |
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Aging Osteoporosis |
Drug: Vitamin K |
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 |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
-
Exclusion Criteria:
Contact: Jennifer Truong, MD | 617-556-3304 | vitaminK@tufts.edu |
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 |
Principal Investigator: | Sarah L Booth, PhD | Tufts Medical Center |
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 |
Vitamin K metabolism Bone health Metabolism |
Antiplasmin Musculoskeletal Diseases Vitamin K Osteoporosis |
Bone Diseases, Metabolic Vitamin K 1 Bone Diseases |
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 |