Comparison of Efficacy of Different Dosages Vitamin K2

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Vitamin K-dependent Proteins; Carboxylation Level

Treatments: Dietary Supplement: vitamin K2; Dietary Supplement: placebo; Dietary Supplement: vitamin K1

Study type: Interventional

Funder types: Other

Identifiers

NCT01194778

08-3-078

Details and patient eligibility

About

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.

Full 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).

Enrollment: 82 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 5 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

The participants of the placebo group will receive daily 1 placebo sachet containing only sucrose

Treatment:

Dietary Supplement: placebo

vitamin K1

Active Comparator group

Description:

The participants of this group will receive daily 1 sachet containing 15 µg vitamin K1.

Treatment:

Dietary Supplement: vitamin K1

vitamin K2 - 15 µg

Active Comparator group

Description:

The participants of this group will receive daily 1 sachet containing 15 µg vitamin K2

Treatment:

Dietary Supplement: vitamin K2

Dietary Supplement: vitamin K2

Dietary Supplement: vitamin K2

vitamin K2 - 30 µg

Active Comparator group

Description:

The participants of this group will receive daily 1 sachet containing 30 µg vitamin K2

Treatment:

Dietary Supplement: vitamin K2

Dietary Supplement: vitamin K2

Dietary Supplement: vitamin K2

vitamin K2 - 45 µg

Active Comparator group

Description:

The participants of this group will receive daily 1 sachet containing 45 µg vitamin K2.

Treatment:

Dietary Supplement: vitamin K2

Dietary Supplement: vitamin K2

Dietary Supplement: vitamin K2