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Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification (K2vita)

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University of Aarhus

Status

Unknown

Conditions

Metabolic Bone Disorder

Treatments

Dietary Supplement: Placebo
Dietary Supplement: K2 vitamin

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

The aims of the present study are to investigate the effect of vitamin K2 on bone turnover, bone mass, bone structure, glucose metabolism, and arteriosclerosis.

Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the Western world.

Our hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.

Full description

Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the Western world.

Our hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.

Enrollment

150 estimated patients

Sex

Female

Ages

60 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • postmenopausal women
  • 60-80 years
  • osteopenia

Exclusion criteria

  • Calcium metabolic, thyroid, liver or kidney disease
  • Diabetes
  • Obesity
  • Myocardial infarction or other arteriosclerotic events
  • Angina pectoris
  • Vitamin D < 50 nmol/L
  • Treatment with vitamin K antagonists
  • Use of vitamin K supplements in the last month or for more than 3 months at any time
  • Treatment with drugs with known effects on bone metabolism or glucose metabolism.
  • Smoking in the last 12 months
  • Drug or alcohol abuse
  • Allergy to calcium, vitamin D or vitamin K.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 2 patient groups, including a placebo group

K2 vitamin
Experimental group
Description:
K2 vitamin 375 microgram a day for 3 years
Treatment:
Dietary Supplement: K2 vitamin
placebo
Placebo Comparator group
Description:
1 tablet a day for 3 years
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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