Biocomparison Study

Overview

The effects of two vitamin K-forms on carboxylation of the vitamin K-dependent proteins osteocalcin and matrix-gla protein will be compared after supplementing these vitamins in a nutritional dose range. The investigators hypothesized that MK-7 is more effective than K1 at a dose comparable to the RDA of vitamin K.

Full Title of Study: “Comparison of Effects of Nutritional Doses Vitamin K1 and K2 on Carboxylation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 2011

Detailed Description

Vitamin K is a group name for the naturally occurring phylloquinone (K1) and menaquinones (MK-n; K2). The latter can be subdivided into the short-chain (e.g. MK-4) and the long-chain (e.g. MK-7, MK-8, and MK-9) menaquinones. Earlier studies have shown that high vitamin K intake leads to improved bone and vascular health by increased carboxylation of vitamin K-dependent proteins in these tissues. In the dietary range, MK-7 has been suggested to be the most effective cofactor for the carboxylation of Gla-proteins, such as osteocalcin (OC) and matrix-Gla protein (MGP).Until now, no randomized controlled trial has compared the efficacy of K1 versus MK-7 in a nutritional dose range. The investigators are therefore interested to compare the effects of K1 and MK-7 on OC and MGP carboxylation after supplementing these vitamins at a dose not exceeding the RDA.

Interventions

  • Dietary Supplement: Placebo
    • 27 participants received for three months 1 placebo capsule per day
  • Dietary Supplement: Vitamin K1-capsules
    • 27 participants received for 3 months 1 vitamin K1-capsule per day containing 52 µg of K1/day
  • Dietary Supplement: Vitamin K2-capsules
    • 27 participants received for 3 months 1 vitamin K2-capsule per day containing 75 µg of MK-7.

Arms, Groups and Cohorts

  • Active Comparator: vitamin K1 capsules
    • 27 participants received for three months 1 vitamin K1-capsule per day containing 52 µg of K1
  • Active Comparator: Vitamin K2-capsules
    • 27 participants received for three months 1 vitamin K2-capsule per day containing 75 µg of MK-7.
  • Placebo Comparator: Placebo capsules
    • 27 participants received for 3 months 1 placebo capsule per day

Clinical Trial Outcome Measures

Primary Measures

  • carboxylation of osteocalcin
    • Time Frame: 12 weeks
    • The primary objective of the study is to compare the effects of K1 and MK-7 on circulating ucOC levels after supplementing these vitamins at a nutritional dose.

Secondary Measures

  • carboxylation of matrix-gla protein
    • Time Frame: 12 weeks
    • The secondary objective of the study is to compare the effects of K1 and MK-7 on circulating ucMGP, which is emerging as a biomarker of arterial calcification.

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy men and women, aged between 20-80 years – Normal body weight and height (18.5 kg/m2 < BMI < 30 kg/m2) – Stable body weight (weight gain or loss < 3 kg in past 3 mo) – Written consent to take part in the study – Agreement to adhere to dietary restrictions required by the protocol Exclusion Criteria:

  • Abuse of drugs and/or alcohol – Use of vitamin supplements containing vitamin K – Pregnancy – (a history of) metabolic or gastrointestinal diseases, e.g. hepatic or renal disorders, osteoporosis – Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, cancer, cardiovascular disease – Use of oral anticoagulants, drugs or hormones that influence bone metabolism – Corticoid treatment – Subjects with anaemia or subjects who recently donated blood or plasma – Systemic treatment or topical treatment likely to interfere with coagulation metabolism (salicylates, antibiotics)

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Maastricht University Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Cees Vermeer, PhD, Principal Investigator, VitaK BV Maastricht University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.