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OpenTrials
Completed

NCT Number: NCT00642551

Beneficial Effects of Long Term Menaquinone-7

From all K-vitamins, menaquinone-7 (MK-7) has been identified now as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin (in bone) and matrix-Gla protein (in the arterial vessel wall). The question remains whether supplementation with MK-7 also leads to measurable improvements of bone and vascular health. The purpose of the study is to demonstrate that MK-7 has a health benefit in apparently healthy postmenopausal women. In a placebo-controlled randomized clinical trial the effect of an MK-7- supplement will be monitored during three years on bone quantity and quality and on vascular characteristics and function.

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Key information

Conditions

Bone Loss Arterial Occlusive Diseases Arteriosclerosis Bone Diseases Bone Diseases, Metabolic Cardiovascular Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

55 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

VitaK BV / Maastricht University

Maastricht, PO Box 616, 6200 MD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy postmenopausal women between 55 and 65 years old
  • Subjects of normal body weight and height according to BMI < 30
  • Subjects of Caucasian race
  • Subject has given written consent to take part in the study

Exclusion criteria

  • Subjects with (a history of) metabolic or gastrointestinal disease
  • Subjects presenting chronic degenerative and/or inflammatory disease
  • Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
  • Subjects receiving corticoϊd treatment
  • Subjects using oral anticoagulants
  • Subject using bisphosphonates
  • Subjects using hormone replacement therapy
  • Subjects undergoing ovariectomy and/or hysterectomy
  • Subject with (a history of) soy allergy
  • Subjects using vitamin K containing multivitamins or vitamin K supplements
  • Subjects who have participated in a clinical study more recently than one month before the current study
  • Subjects who are found to be osteoporotic at baseline (T-score < -2.5)

Treatment and study plan

menaquinone-7

Dietary Supplement

180 µg menaquinone-7 daily for three years

Placebo

Dietary Supplement

1 placebo capsule daily for three years

Primary outcomes

  1. Bone mineral density, bone mineral content and bone geometry measured by DEXA. Vascular elasticity, intima-media thickness and pulse wave velocity measured by ultrasound

    Time frame: three years

Secondary outcomes

  1. The vitamin K-dependent proteins: uncarboxylated osteocalcin (ucOC), carboxylated osteocalcin (cOC), uncarboxylated matrix-Gla protein (ucMGP) and carboxylated matrix-Gla protein cMGP)

    Time frame: three years

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Clinical Trial on Beneficial Effects of Long Term Menaquinone-7 (Vitamin K2) Intake by Postmenopausal Women

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 25, 2008
Registry last updated
Jun 12, 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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