Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet Intervention | Experimental | 28 day diet low vitamin K, 28 day diet high vitamin K |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K | Drug | phylloquinone (vitamin K1) 500 mcg daily in third month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Phylloquinone | Plasma phylloquinone in response to phylloquinone depletion and repletion | 2 months |
Not provided
Not provided
Inclusion Criteria:
-
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sarah L Booth, PhD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Mayer United States Department of Agriculture Human Nutrition Research Center on Aging at Tufts University | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15722567 | Background | 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. | |
| 14767874 | Background | 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. |
| Label | URL |
|---|---|
| Jean Mayer USDA Human Nutrition Research Center on Aging site | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin K Diet Intervention | 5 day baseline vitamin K Vitamin K: phylloquinone (vitamin K1) 200 mcg daily 28 day diet low vitamin K Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days treatment started day 6, completed day 33 28 day diet high vitamin K Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month treatment started day 34, ended day 61 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (200mcg Daily) |
| |||||||||||||
| Low Vitamin K (10mcg Daily) |
| |||||||||||||
| High Vitamin K (500mcg Daily) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Diet Intervention | 5 day baseline vitamin K Vitamin K: phylloquinone (vitamin K1) 200 mcg daily 28 day diet low vitamin K Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days treatment started day 6, completed day 33 28 day diet high vitamin K Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month treatment started day 34, ended day 61 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Phylloquinone | Plasma phylloquinone in response to phylloquinone depletion and repletion | Posted | Mean | Standard Deviation | nmol/L | 2 months |
|
|
duration of study, up to 62 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diet Intervention | 5 day baseline vitamin K Vitamin K: phylloquinone (vitamin K1) 200 mcg daily 28 day diet low vitamin K Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days treatment started day 6, completed day 33 28 day diet high vitamin K Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month treatment started day 34, ended day 61 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High blood pressure | Blood and lymphatic system disorders | Non-systematic Assessment | not related to intervention |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Booth, PhD | Tufts University | 617-556-3231 | sarah.booth@tufts.edu |
Not provided
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D010837 | Vitamin K 1 |
| ID | Term |
|---|---|
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12888638 | Background | 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. |
| 11722960 | Background | 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. |
| 25739929 | Result | 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. |
| 22437558 | Result | 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. |
| 30590596 | Derived | 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Plasma phylloquinone (nmol/L) | Mean | Standard Deviation | nmol/L |
|
|
|
| 0 |
| 42 |
| 3 |
| 42 |
|
| History of blood clotting | Blood and lymphatic system disorders | Non-systematic Assessment | ineligible for study enrollment |
|
| Facial swelling | General disorders | Non-systematic Assessment | not related to intervention |
|
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D011809 | Quinones |