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.

Study Overview

• Status: Completed
• Conditions: Carboxylation Level; Vitamin K-dependent Proteins
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: vitamin K1; Dietary supplement: vitamin K2; Dietary supplement: vitamin K2; Dietary supplement: vitamin K2

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

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229 EV
    • VitaK BV Maastricht University

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

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	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; 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
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; 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
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; 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

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).	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	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

• Sponsor: Maastricht University Medical Center

Study record dates

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: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Micronutrients; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamin K; Vitamins; Vitamin K 1; Vitamin K 2
• Other Study ID Numbers: 08-3-078