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Determinants of Vitamin K Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00336232
Recruitment Status : Completed
First Posted : June 13, 2006
Results First Posted : May 30, 2016
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Sarah Booth, Tufts University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions: Aging
Osteoporosis
Intervention: Drug: Vitamin K

  Participant Flow

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
No text entered.

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

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 
Overall Participants Analyzed 
[Units: Participants]
 42 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      31  73.8% 
>=65 years      11  26.2% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      21  50.0% 
Male      21  50.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2   4.8% 
Not Hispanic or Latino      40  95.2% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      5  11.9% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      4   9.5% 
White      32  76.2% 
More than one race      1   2.4% 
Unknown or Not Reported      0   0.0% 
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

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
No text entered.


  More Information

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 ( U.S. NIH Grant/Contract )
First Submitted: June 12, 2006
First Posted: June 13, 2006
Results First Submitted: March 7, 2016
Results First Posted: May 30, 2016
Last Update Posted: November 27, 2017