Clinical trial NCT01922804: Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification
Official title: Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Bone Disorder
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Axellus
First posted: 2013-08-14
Enrollment: 150
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: p-undercarboxylated osteocalcin
timeFrame: 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
timeFrame: Assessed after 3, 6, 12, 24 and 36 months
measure: Change in arterial stiffness, pulse wave velocity
timeFrame: Measured at baseline and after 6 months
measure: Change in insulin sensitivity
timeFrame: Measured at baseline and after 1 and 12 months.
measure: Change in bone turnover markers
timeFrame: Measured at baseline, after 1, 3, 6, 12, 24 and 36 months
measure: Change in bone structure
timeFrame: baseline and month 12
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Endocrinology and Internal Medicine THG
Study officials:
affiliation: Aarhus University Hospital
name: Sofie Rønn, cand.med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ronn SH, Harslof T, Oei L, Pedersen SB, Langdahl BL. The effect of vitamin MK-7 on bone mineral density and microarchitecture in postmenopausal women with osteopenia, a 3-year randomized, placebo-controlled clinical trial. Osteoporos Int. 2021 Jan;32(1):185-191. doi: 10.1007/s00198-020-05638-z. Epub 2020 Oct 8.