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

June 6, 2007
March 9, 2009
May 2007
October 2007   (final data collection date for primary outcome measure)
  • undercarboxylated osteocalcin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • carboxylated osteocalcin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • undercarboxylated osteocalcin [ Time Frame: 12 weeks ]
  • carboxylated osteocalcin [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00483431 on ClinicalTrials.gov Archive Site
  • 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 ]
  • undercarboxylated matrix-gla protein [ Time Frame: 12 weeks ]
  • carboxylated matrix-gla protein [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
Dose-Finding Study for Vitamin K2 in Human Volunteers
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Vitamin K-Status
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00483431
MEC 07-3-014
No
Dr.C.Vermeer, VitaK BV
Maastricht University Medical Center
Not Provided
Principal Investigator: Cees Vermeer, PhD Maastricht University
Maastricht University Medical Center
March 2009

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