Determinants of Vitamin K Metabolism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sarah Booth, Tufts University
ClinicalTrials.gov Identifier:
NCT00336232
First received: June 12, 2006
Last updated: April 22, 2016
Last verified: April 2016
Results First Received: March 7, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Conditions: Aging
Osteoporosis
Intervention: Drug: Vitamin K

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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


Participant Flow for 3 periods

Period 1:   Baseline (200mcg Daily)
    Vitamin K Diet Intervention  
STARTED     59  
COMPLETED     42  
NOT COMPLETED     17  

Period 2:   Low Vitamin K (10mcg Daily)
    Vitamin K Diet Intervention  
STARTED     42  
COMPLETED     42  
NOT COMPLETED     0  

Period 3:   High Vitamin K (500mcg Daily)
    Vitamin K Diet Intervention  
STARTED     42  
COMPLETED     42  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Baseline Measures
    Diet Intervention  
Number of Participants  
[units: participants]
  42  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     31  
>=65 years     11  
Gender  
[units: participants]
 
Female     21  
Male     21  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     2  
Not Hispanic or Latino     40  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     5  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     32  
More than one race     1  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     42  
Plasma phylloquinone (nmol/L)  
[units: nmol/L]
Mean (Standard Deviation)
  0.8  (1.1)  



  Outcome Measures

1.  Primary:   Plasma Phylloquinone   [ Time Frame: 2 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sarah Booth, PhD
Organization: Tufts University
phone: 617-556-3231
e-mail: sarah.booth@tufts.edu


Publications of Results:
Other Publications:

Responsible Party: Sarah Booth, Tufts University
ClinicalTrials.gov Identifier: NCT00336232     History of Changes
Other Study ID Numbers: R01DK069341 ( US NIH Grant/Contract Award Number )
Study First Received: June 12, 2006
Results First Received: March 7, 2016
Last Updated: April 22, 2016
Health Authority: United States: Federal Government