Clinical trial NCT01194778: Comparison of Efficacy of Different Dosages Vitamin K2
Official title: Comparison of Efficacy of Different Dosages Vitamin K2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carboxylation Level
Vitamin K-dependent Proteins
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2010-09-03
Enrollment: 82
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
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).
timeFrame: 12 weeks
Secondary outcomes:
measure: the number or type of bacteria in the stool
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: VitaK BV Maastricht University
Study officials:
affiliation: VitaK BV Maastricht University
name: Cees Vermeer, PhD
role: PRINCIPAL_INVESTIGATOR
References: