Comparison of Efficacy of Different Dosages Vitamin K2

• ClinicalTrials.gov Identifier: NCT01194778
• Recruitment Status: Completed
• First Posted: September 3, 2010
• Last Update Posted: September 3, 2010
• Sponsor: Maastricht University Medical Center
• Information provided by: Maastricht University Medical Center

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Carboxylation Level; Vitamin K-dependent Proteins	Dietary Supplement: placebo; Dietary Supplement: vitamin K1; Dietary Supplement: vitamin K2	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Efficacy of Different Dosages Vitamin K2
• Study Start Date: October 2009
• Actual Primary Completion Date: February 2010
• Actual Study Completion Date: August 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Dr. C. Vermeer, Maastricht UMC
• ClinicalTrials.gov Identifier: NCT01194778
• Other Study ID Numbers: 08-3-078
• First Posted: September 3, 2010
• Last Update Posted: September 3, 2010
• Last Verified: September 2010

Additional relevant MeSH terms:

Vitamins; Vitamin K; Vitamin K 2; Vitamin K 1; Micronutrients; Physiological Effects of Drugs; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants