- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01194778
Comparison of Efficacy of Different Dosages Vitamin K2
September 2, 2010 updated by: Maastricht University Medical Center
Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green vegetables, K2 is of microbial origin.
Lactic bacteria produce a mixture of higher menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9.
Nothing is known yet about the efficacy of bacterial K2 vitamins for in vivo K function (carboxylation of essential proteins).
Therefore, this study was undertaken to study effects of different dosages of bacterial vitamin K2 on carboxylation of extrahepatic proteins.
Study Overview
Status
Completed
Conditions
Detailed Description
Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green vegetables, K2 is of microbial origin.
Lactic bacteria produce a mixture of higher menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9.
Higher menaquinones not only have very long half-life times (over 3 days rather than 1 hour for vitamin K1); K2 vitamins are also transported to extra hepatic tissues such as bone and vessel wall whereas K1 is preferentially transported to the liver.
Nothing is known yet about the efficacy of bacterial K2 vitamins for in vivo K function (carboxylation of essential proteins).
This study describes a dose-response experiment for different dosages of bacterial K2 which are compared with one selected dose of K1 and placebo.
The efficacy is concluded from the carboxylation of the bone Gla-protein osteocalcin and of the vascular Gla-protein matrix-Gla protein (MGP).
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Maastricht, Netherlands, 6229 EV
- VitaK BV Maastricht University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy men and women between 40 and 60 years old
- Subjects of normal body weight and height according to BMI < 30
- Subjects of Caucasian race
- Subject has given written consent to take part in the study
Exclusion Criteria:
- Subjects with (a history of) metabolic or gastrointestinal disease
- Subjects presenting chronic degenerative and/or inflammatory disease
- Subjects presenting diabetes mellitus
- Abuse of drugs and/or alcohol
- Subjects receiving corticoϊd treatment including inhalators
- Subjects using oral anticoagulants
- Subjects using vitamin K containing multivitamins or vitamin K supplements
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: placebo
The participants of the placebo group will receive daily 1 placebo sachet containing only sucrose
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1 placebo sachet per day containing only sucrose during 12 weeks
|
ACTIVE_COMPARATOR: vitamin K1
The participants of this group will receive daily 1 sachet containing 15 µg vitamin K1.
|
15 µg vitamin K1 per day during 12 weeks
|
ACTIVE_COMPARATOR: vitamin K2 - 15 µg
The participants of this group will receive daily 1 sachet containing 15 µg vitamin K2
|
15 µg vitamin K2 per day during 12 weeks
30 µg vitamin K2 per day during 12 weeks
45 µg vitamin K2 per day during 12 weeks
|
ACTIVE_COMPARATOR: vitamin K2 - 30 µg
The participants of this group will receive daily 1 sachet containing 30 µg vitamin K2
|
15 µg vitamin K2 per day during 12 weeks
30 µg vitamin K2 per day during 12 weeks
45 µg vitamin K2 per day during 12 weeks
|
ACTIVE_COMPARATOR: vitamin K2 - 45 µg
The participants of this group will receive daily 1 sachet containing 45 µg vitamin K2.
|
15 µg vitamin K2 per day during 12 weeks
30 µg vitamin K2 per day during 12 weeks
45 µg vitamin K2 per day during 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The concentration of the circulating biochemical markers matrix-Gla protein and osteocalcin. Both proteins will be measured in their active form (carboxylated form) and their inactive form (undercarboxylated form).
Time Frame: 12 weeks
|
The main purpose of the study is to investigate the efficacy of different dosages bacterial vitamin K2 and vitamin K1 on carboxylation degree of the vitamin K-dependent proteins osteocalcin and matrix-gla protein.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the number or type of bacteria in the stool
Time Frame: 12 weeks
|
The second purpose of the study is to monitor whether the increased vitamin K intake will change the composition of the intestinal flora, as measured from the collected stools.
Vitamin K, notably K2 is produced by a number of colonic bacteria and our principal is interested to learn whether the intake of extra vitamin K will affect the number or type of bacteria in the stool.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (ACTUAL)
February 1, 2010
Study Completion (ACTUAL)
August 1, 2010
Study Registration Dates
First Submitted
August 5, 2010
First Submitted That Met QC Criteria
September 2, 2010
First Posted (ESTIMATE)
September 3, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
September 3, 2010
Last Update Submitted That Met QC Criteria
September 2, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-3-078
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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