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Comparison of Efficacy of Different Dosages Vitamin K2

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01194778
First received: August 5, 2010
Last updated: September 2, 2010
Last verified: September 2010
History of Changes

August 5, 2010
September 2, 2010
October 2009
February 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01194778 on ClinicalTrials.gov Archive Site
the number or type of bacteria in the stool [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Comparison of Efficacy of Different Dosages Vitamin K2
Comparison of Efficacy of Different Dosages Vitamin K2

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.

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).
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Carboxylation Level
  • Vitamin K-dependent Proteins
  • Dietary Supplement: placebo
    1 placebo sachet per day containing only sucrose during 12 weeks
  • Dietary Supplement: vitamin K1
    15 µg vitamin K1 per day during 12 weeks
  • Dietary Supplement: vitamin K2
    15 µg vitamin K2 per day during 12 weeks
  • Dietary Supplement: vitamin K2
    30 µg vitamin K2 per day during 12 weeks
  • Dietary Supplement: vitamin K2
    45 µg vitamin K2 per day during 12 weeks
  • Placebo Comparator: placebo
    The participants of the placebo group will receive daily 1 placebo sachet containing only sucrose
    Intervention: Dietary Supplement: placebo
  • Active Comparator: vitamin K1
    The participants of this group will receive daily 1 sachet containing 15 µg vitamin K1.
    Intervention: Dietary Supplement: vitamin K1
  • Active Comparator: vitamin K2 - 15 µg
    The participants of this group will receive daily 1 sachet containing 15 µg vitamin K2
    Intervention: Dietary Supplement: vitamin K2
  • Active Comparator: vitamin K2 - 30 µg
    The participants of this group will receive daily 1 sachet containing 30 µg vitamin K2
    Intervention: Dietary Supplement: vitamin K2
  • Active Comparator: vitamin K2 - 45 µg
    The participants of this group will receive daily 1 sachet containing 45 µg vitamin K2.
    Intervention: Dietary Supplement: vitamin K2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
August 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01194778
08-3-078
No
Dr. C. Vermeer, Maastricht UMC
Maastricht University Medical Center
Not Provided
Principal Investigator: Cees Vermeer, PhD VitaK BV Maastricht University
Maastricht University Medical Center
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP