Dose-finding Study for Vitamin K2 in Human Volunteers

Vitamin K-status Clinical Trial

Official title:

Dose-finding Study for Vitamin K2 in Human Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483431
• Other study ID #: MEC 07-3-014
• Status: Completed
• Phase: N/A
• First received: June 6, 2007
• Last updated: April 26, 2018
• Start date: May 2007
• Est. completion date: October 2007

Study information

• Verified date: March 2009
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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 cortico?d treatment

• Subjects using oral anticoagulants

Related Conditions & MeSH terms

• Vitamin K-status

Intervention

Dietary Supplement:
• Placebo

• MK7

Locations

Country	Name	City	State
Netherlands	VitaK BV / University of Maastricht	Maastricht	PO Box 616

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	undercarboxylated osteocalcin (ucOC)	UcOC will be assessed by making use of a sandwich ELISA (in ng/ml)	12 weeks
Secondary	carboxylated osteocalcin (cOC)	cOC will be assessed by making use of a sandwich ELISA (in ng/ml)	12 weeks
Secondary	undercarboxylated matrix-gla protein (ucMGP)	ucMGP will be assessed by making use of a sandwich ELISA (in pM)	12 weeks