Dose-Finding Study for Vitamin K2 in Human Volunteers

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)

Phase: N/A

Status: Completed

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

Primary outcome:

undercarboxylated osteocalcin

carboxylated osteocalcin

Secondary outcome:

undercarboxylated matrix-gla protein

carboxylated matrix-gla protein

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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

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