Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- p-undercarboxylated osteocalcin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •postmenopausal women
- •60-80 years
- •osteopenia
排除标准
- •Calcium metabolic, thyroid, liver or kidney disease
- •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.
结局指标
主要结局
p-undercarboxylated osteocalcin
时间窗: Change in undercarboxylated osteocalcin in plasma after 3 month treatment compared to baseline. Analysed in batch after the end of trial.
次要结局
- Change in bone mineral density(Assessed after 3, 6, 12, 24 and 36 months)
- Change in insulin sensitivity(Measured at baseline and after 1 and 12 months.)
- Change in arterial stiffness, pulse wave velocity(Measured at baseline and after 6 months)
- Change in bone turnover markers(Measured at baseline, after 1, 3, 6, 12, 24 and 36 months)
- Change in bone structure(baseline and month 12)