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, Parallel 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 Medical Center

Overall Clinical Trial Officials and Contacts

Cees Vermeer, PhD Principal Investigator Maastricht University Medical Center  

Information obtained from ClinicalTrials.gov on July 02, 2009

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)