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Dose-finding Study for Vitamin K2 in Human Volunteers

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ClinicalTrials.gov Identifier: NCT00483431
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

June 6, 2007
June 7, 2007
April 27, 2018
May 2007
October 2007   (Final data collection date for primary outcome measure)
undercarboxylated osteocalcin (ucOC) [ Time Frame: 12 weeks ]
UcOC will be assessed by making use of a sandwich ELISA (in ng/ml)
  • 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
  • carboxylated osteocalcin (cOC) [ Time Frame: 12 weeks ]
    cOC will be assessed by making use of a sandwich ELISA (in ng/ml)
  • undercarboxylated matrix-gla protein (ucMGP) [ Time Frame: 12 weeks ]
    ucMGP will be assessed by making use of a sandwich ELISA (in pM)
  • 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 (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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Vitamin K-status
  • Dietary Supplement: Placebo
  • Dietary Supplement: MK7
    Other Name: Menaquinone-7
  • Placebo Comparator: PLACEBO
    MK7 dosage 0 mcg, 4 capsules, orally, daily for 12 weeks.
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: MK7_10
    MK7 dosage 10 mcg, 1 capsule of 10 mcg and 3 placebo-capsules, orally, daily for 12 weeks.
    Intervention: Dietary Supplement: MK7
  • Active Comparator: MK7_20
    MK7 dosage 20 mcg, 2 capsules of 10 mcg and 2 placebo-capsules, orally, daily for 12 weeks.
    Intervention: Dietary Supplement: MK7
  • Active Comparator: MK7_45
    MK7 dosage 45 mcg, 1 capsules of 45 mcg and 3 placebo-capsules, orally, daily for 12 weeks.
    Intervention: Dietary Supplement: MK7
  • Active Comparator: MK7_90
    MK7 dosage 90 mcg, 2 capsules of 45 mcg and 2 placebo-capsules, orally, daily for 12 weeks.
    Intervention: Dietary Supplement: MK7
  • Active Comparator: MK7_180
    MK7 dosage 180 mcg, 4 capsules of 45 mcg, orally, daily for 12 weeks.
    Intervention: Dietary Supplement: MK7
  • Active Comparator: MK7_360
    MK7 dosage 360 mcg, 1 capsule of 360 mcg and 3 placebo-capsules, orally, daily for 12 weeks.
    Intervention: Dietary Supplement: MK7

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
Same as current
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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00483431
MEC 07-3-014
No
Not Provided
Not Provided
Maastricht University Medical Center
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