Dose-Finding Study for Vitamin K2 in Human Volunteers
Information source: Maastricht University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin K-Status
Intervention: no vitamin K (Dietary Supplement); 10 mcg Vitamin K for 3 months daily (Dietary Supplement); 20 mcg Vitamin K for 3 months daily (Dietary Supplement); 45 mcg Vitamin K for 3 months daily (Dietary Supplement); 90 mcg Vitamin K for 3 months daily (Dietary Supplement); 180 mcg Vitamin K for 3 months daily (Dietary Supplement); 360 mcg Vitamin K for 3 months daily (Genetic)
Sponsored by: Maastricht University
Official(s) and/or principal investigator(s):
Cees Vermeer, PhD, Principal Investigator, Affiliation: Maastricht University
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.
Official title: Dose-Finding Study for Vitamin K2 in Human Volunteers
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment
undercarboxylated matrix-gla protein
carboxylated matrix-gla protein
Minimum age: 18 Years.
Maximum age: 45 Years.
- 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
- 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
Locations and Contacts
VitaK BV / University of Maastricht, Maastricht, PO Box 616 6200 MD, Netherlands
Starting date: May 2007
Ending date: October 2007
Last updated: March 25, 2008