Comparison of Efficacy of Different Dosages Vitamin K2
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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 |
- 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.
- 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 |
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| Netherlands | |
| VitaK BV Maastricht University | |
| Maastricht, Netherlands, 6229 EV | |
| 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 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 May 19, 2013