Overview

This trial is active, not recruiting.

Condition metabolic bone disorder
Treatments k2 vitamin, placebo
Sponsor University of Aarhus
Collaborator Axellus
Start date July 2013
End date April 2017
Trial size 150 participants
Trial identifier NCT01922804, K2vita

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
K2 vitamin 375 microgram a day for 3 years
k2 vitamin
K2 vitamin tablet
(Placebo Comparator)
1 tablet a day for 3 years
placebo
Placebo tablets

Primary Outcomes

Measure
p-undercarboxylated osteocalcin
time frame: Change in undercarboxylated osteocalcin in plasma after 3 month treatment compared to baseline. Analysed in batch after the end of trial.

Secondary Outcomes

Measure
Change in bone mineral density
time frame: Assessed after 3, 6, 12, 24 and 36 months
Change in arterial stiffness, pulse wave velocity
time frame: Measured at baseline and after 6 months
Change in insulin sensitivity
time frame: Measured at baseline and after 1 and 12 months.
Change in bone turnover markers
time frame: Measured at baseline, after 1, 3, 6, 12, 24 and 36 months
Change in bone structure
time frame: baseline and month 12

Eligibility Criteria

Female participants from 60 years up to 80 years old.

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.

Additional Information

Official title Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification
Principal investigator Sofie Rønn, cand.med
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Aarhus.