NCT01928134已完成不适用
The Efficacy of Vitamin K2 on Human Osteoporosis, Blood-vessel Calcification and Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline in Serum Calcium
研究概览
简要总结
This study used the generally recognized as safe (GRAS) grade of Bacillus subtilis natto to produce Vitamin K2, Menaquinone-7(MK-7), via fermentation, for functional evaluation. There are four major objectives for this study: (1) bioavailability of calcium; (2) evaluation of bone density improvement; (3) evaluation of blood-vessel calcification and sclerosis improvement; (4) safety evaluation.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and non-pregnant women who are at least 20 years and under 75 years of age; and
- •Female subjects cannot be pregnant or breast feeding.
- •Patients who are, in the opinion of the Investigator, able to comply with the requirements of the study; and
- •Patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication.
排除标准
- •Women who are pregnant, as determined by a urine pregnancy test, or breast-feeding.
- •Presence or history of congestive heart failure (NYHA class III/IV) within the prior 12 weeks.
- •Recent myocardial infarction (within the prior 12 weeks).
- •Unstable angina pectoris.
- •Known or suspected renal insufficiency defined as creatinine>1.5mg/dl.
- •Known or suspected hepatic insufficiency defined as abnormal liver function tests (GOT/GPT) >3x upper normal limit (i.e., 120 U/l).
- •Known hypomotility syndrome: (such as hypothyroidism or scleroderma).
- •Recent major trauma within the prior 12 weeks.
- •Recent surgery requiring anesthesia including coronary artery bypass graft (within 12 weeks).
- •Recent hospitalization (within 12 weeks)
- •Uncontrolled hypertension (defined as a systolic blood pressure>180mmHg or a diastolic blood pressure >105mmHg).
- •Uncontrolled hyperlipidemia (defined as total cholesterol>240mg/dL or triglyceride >200mg/dL).
- •Uncontrolled diabetes (defined as HbA1c>7%).
- •Cigarette smoker (>=1/day).
- •Acute infection requiring current antibiotic therapy.
- •Current use of anticoagulant medication (e.g., warfarin).
- •Recent or abrupt change (within 1 month) in usual diet.
- •Use of an investigational drug (within 30 days prior to enrollment).
- •Known allergies to the component of study medication
- •Patients have acute disease, and in the opinion of investigators, are not suitable to participate in this study.
结局指标
主要结局
Change from baseline in Serum Calcium
时间窗: at 4 hours after intake
次要结局
- Change from baseline in urine calcium/creatinine ratio(at 4 hours after intake)
研究者
Shih-Li Su
Attending Physician of Section of Endocrinology and Metabolism
Changhua Christian Hospital
研究点 (2)
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