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Completed

NCT Number: NCT01638182

Biocomparison Study

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VitaK BV / Maastricht University Medicial Center

Maastricht, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Placebo

Dietary Supplement

27 participants received for three months 1 placebo capsule per day

Vitamin K1-capsules

Dietary Supplement

27 participants received for 3 months 1 vitamin K1-capsule per day containing 52 µg of K1/day

Vitamin K2-capsules

Dietary Supplement

27 participants received for 3 months 1 vitamin K2-capsule per day containing 75 µg of MK-7.

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Comparison of Effects of Nutritional Doses Vitamin K1 and K2 on Carboxylation

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 11, 2012
Registry last updated
Jul 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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