Dose-finding Study for Vitamin K2 in Human Volunteers

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Vitamin K-status

Treatments: Dietary Supplement: MK7; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00483431

MEC 07-3-014

Details and patient eligibility

About

Earlier studies have shown that high vitamin K-intake leads to improved bone and vascular health by increased carboxylation of Gla-proteins in these tissues. From all K-vitamins, Menaquinone-7 (MK7) has been identified as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin and matrix-gla protein. The question remains which dosage of MK7 leads to optimal carboxylation levels of these proteins.

The primary objective of this double-blind randomized intervention study is to establish the optimal dose of MK7 for carboxylation of the vitamin K-dependent proteins osteocalcin in bone and matrix-gla protein in the vessel wall. The optimal dose will be the concentration at which osteocalcin and matrix-gla protein are > 90% in the active (=carboxylated) form.

Full description

This study is a double-blind randomized intervention study. In total 42 healthy volunteers (men and women) between 18 and 45 years will be recruited among the Maastricht University community (coworkers/students) and randomized into one of the following groups:

Placebo, 10 mcg MK7, 20 mcg MK7, 45 mcg MK7, 90 mcg MK7, 180 mcg MK7, 360 mcg MK7.

Each group will consist of 6 volunteers with approximately equal numbers of men and women (3 men / 3 women). A double-blind design of the study is chosen to avoid the occurrence of bias during the study. The randomization procedure will be performed by an investigator who is not involved in the coordination of the study and will generate specific randomization codes for each subject. After randomization, the volunteers consume the indicated amount of capsules once daily with either breakfast of dinner during a period of 12 weeks.

During the first week, blood samples of the volunteers will be collected at day 0, 1, 3 and 7 to study immediate effects on carboxylation of OC and MGP. After the first week, blood samples will be drawn every first day of week 2, 4, 6, 8, 10, and 12.

Enrollment: 42 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female adults between 18 and 45 years of age.
• Subjects of normal body weight and height according to BMI < 30
• Subject has given written consent to take part in the study

Exclusion criteria

• Subjects with (a history of) metabolic or gastrointestinal disease
• Subject with (a history of) soy allergy
• Subjects using vitamin supplements containing vitamin K
• Subjects presenting chronic inflammatory diseases
• Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
• Subjects receiving corticoϊd treatment
• Subjects using oral anticoagulants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 7 patient groups, including a placebo group

PLACEBO

Placebo Comparator group

Description:

MK7 dosage 0 mcg, 4 capsules, orally, daily for 12 weeks.

Treatment:

Dietary Supplement: Placebo

MK7_10

Active Comparator group

Description:

MK7 dosage 10 mcg, 1 capsule of 10 mcg and 3 placebo-capsules, orally, daily for 12 weeks.

Treatment:

Dietary Supplement: MK7

MK7_20

Active Comparator group

Description:

MK7 dosage 20 mcg, 2 capsules of 10 mcg and 2 placebo-capsules, orally, daily for 12 weeks.

Treatment:

Dietary Supplement: MK7

MK7_45

Active Comparator group

Description:

MK7 dosage 45 mcg, 1 capsules of 45 mcg and 3 placebo-capsules, orally, daily for 12 weeks.

Treatment:

Dietary Supplement: MK7

MK7_90

Active Comparator group

Description:

MK7 dosage 90 mcg, 2 capsules of 45 mcg and 2 placebo-capsules, orally, daily for 12 weeks.

Treatment:

Dietary Supplement: MK7

MK7_180

Active Comparator group

Description:

MK7 dosage 180 mcg, 4 capsules of 45 mcg, orally, daily for 12 weeks.

Treatment:

Dietary Supplement: MK7

MK7_360

Active Comparator group

Description:

MK7 dosage 360 mcg, 1 capsule of 360 mcg and 3 placebo-capsules, orally, daily for 12 weeks.

Treatment:

Dietary Supplement: MK7