Official Title: “Dose-Finding Study for Vitamin K2 in Human Volunteers”

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 (MK-7) 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 MK-7 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 MK-7 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

• Dietary Supplement: no vitamin K
  • no vitamin K
• Dietary Supplement: 10 mcg Vitamin K for 3 months daily
  • 10 mcg Vitamin K for 3 months daily
• Dietary Supplement: 20 mcg Vitamin K for 3 months daily
  • 20 mcg Vitamin K for 3 months daily
• Dietary Supplement: 45 mcg Vitamin K for 3 months daily
  • 45 mcg Vitamin K for 3 months daily
• Dietary Supplement: 90 mcg Vitamin K for 3 months daily
  • 90 mcg Vitamin K for 3 months daily
• Dietary Supplement: 180 mcg Vitamin K for 3 months daily
  • 180 mcg Vitamin K for 3 months daily
• Genetic: 360 mcg Vitamin K for 3 months daily
  • 360 mcg Vitamin K for 3 months daily

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1
• Active Comparator: 2
  • 10 mcg Vitamin K
• Active Comparator: 3
  • 20 mcg Vitamin K
• Active Comparator: 4
  • 45 mcg Vitamin K
• Active Comparator: 5
  • 90 mcg Vitamin K
• Active Comparator: 6
  • 180 mcg Vitamin K
• Active Comparator: 7
  • 360 mcg Vitamin K for 3 months daily

Primary Measures

• undercarboxylated osteocalcin
  • Time Frame: 12 weeks
    Safety Issue?: No
• carboxylated osteocalcin
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• undercarboxylated matrix-gla protein
  • Time Frame: 12 weeks
    Safety Issue?: No
• carboxylated matrix-gla protein
  • Time Frame: 12 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Maastricht University

Overall Clinical Trial Officials and Contacts

Cees Vermeer, PhD Principal Investigator Maastricht University  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00483431

Study ID Number: MEC 07-3-014

ClinicalTrials.gov Identifier: NCT00483431

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)