Dose-Finding Study for Vitamin K2 in Human Volunteers

This study has been completed.

Sponsor:

Information provided by:

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT00483431

First received: June 6, 2007

Last updated: March 9, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 6, 2007

Last Updated Date

March 9, 2009

Start Date ^ICMJE

May 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

undercarboxylated osteocalcin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
carboxylated osteocalcin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

undercarboxylated osteocalcin [ Time Frame: 12 weeks ]
carboxylated osteocalcin [ Time Frame: 12 weeks ]

Change History

Complete list of historical versions of study NCT00483431 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

undercarboxylated matrix-gla protein [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
carboxylated matrix-gla protein [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

undercarboxylated matrix-gla protein [ Time Frame: 12 weeks ]
carboxylated matrix-gla protein [ Time Frame: 12 weeks ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Dose-Finding Study for Vitamin K2 in Human Volunteers

Official Title ^ICMJE

Dose-Finding Study for Vitamin K2 in Human Volunteers

Brief 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 (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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Vitamin K-Status

Intervention ^ICMJE

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

Study Arm (s)

No Intervention: 1
Intervention: Dietary Supplement: no vitamin K
Active Comparator: 2
10 mcg Vitamin K

Intervention: Dietary Supplement: 10 mcg Vitamin K for 3 months daily
Active Comparator: 3
20 mcg Vitamin K

Intervention: Dietary Supplement: 20 mcg Vitamin K for 3 months daily
Active Comparator: 4
45 mcg Vitamin K

Intervention: Dietary Supplement: 45 mcg Vitamin K for 3 months daily
Active Comparator: 5
90 mcg Vitamin K

Intervention: Dietary Supplement: 90 mcg Vitamin K for 3 months daily
Active Comparator: 6
180 mcg Vitamin K

Intervention: Dietary Supplement: 180 mcg Vitamin K for 3 months daily
Active Comparator: 7
360 mcg Vitamin K for 3 months daily

Intervention: Genetic: 360 mcg Vitamin K for 3 months daily

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00483431

Other Study ID Numbers ^ICMJE

MEC 07-3-014

Has Data Monitoring Committee

Responsible Party

Dr.C.Vermeer, VitaK BV

Study Sponsor ^ICMJE

Maastricht University Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Cees Vermeer, PhD

Maastricht University

Information Provided By

Maastricht University Medical Center

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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