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
  Purpose

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.


Condition Intervention
Carboxylation Level
Vitamin K-dependent Proteins
Dietary Supplement: placebo
Dietary Supplement: vitamin K1
Dietary Supplement: vitamin K2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy of Different Dosages Vitamin K2

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 82
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
The participants of the placebo group will receive daily 1 placebo sachet containing only sucrose
Dietary Supplement: placebo
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.
Dietary Supplement: 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
Dietary Supplement: vitamin K2
15 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
Dietary Supplement: vitamin K2
30 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.
Dietary Supplement: vitamin K2
45 µg vitamin K2 per day during 12 weeks

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).

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194778

Locations
Netherlands
VitaK BV Maastricht University
Maastricht, Netherlands, 6229 EV
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Cees Vermeer, PhD VitaK BV Maastricht University
  More Information

No publications provided

Responsible Party: Dr. C. Vermeer, Maastricht UMC
ClinicalTrials.gov Identifier: NCT01194778     History of Changes
Other Study ID Numbers: 08-3-078
Study First Received: August 5, 2010
Last Updated: September 2, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Vitamin K 1
Vitamin K
Vitamins
Vitamin K 2
Vitamin MK 7
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014