Clinical Trial on Beneficial Effects of Long Term Menaquinone-7 (Vitamin K2) Intake by Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Bone mineral density, bone mineral content and bone geometry measured by DEXA. Vascular elasticity, intima-media thickness and pulse wave velocity measured by ultrasound
研究概览
简要总结
From all K-vitamins, menaquinone-7 (MK-7) has been identified now as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin (in bone) and matrix-Gla protein (in the arterial vessel wall). The question remains whether supplementation with MK-7 also leads to measurable improvements of bone and vascular health. The purpose of the study is to demonstrate that MK-7 has a health benefit in apparently healthy postmenopausal women. In a placebo-controlled randomized clinical trial the effect of an MK-7- supplement will be monitored during three years on bone quantity and quality and on vascular characteristics and function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy postmenopausal women between 55 and 65 years old
- •Subjects of normal body weight and height according to BMI < 30
- •Subjects of Caucasian race
- •Subject has given written consent to take part in the study
排除标准
- •Subjects with (a history of) metabolic or gastrointestinal disease
- •Subjects presenting chronic degenerative and/or inflammatory disease
- •Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
- •Subjects receiving corticoϊd treatment
- •Subjects using oral anticoagulants
- •Subject using bisphosphonates
- •Subjects using hormone replacement therapy
- •Subjects undergoing ovariectomy and/or hysterectomy
- •Subject with (a history of) soy allergy
- •Subjects using vitamin K containing multivitamins or vitamin K supplements
- •Subjects who have participated in a clinical study more recently than one month before the current study
- •Subjects who are found to be osteoporotic at baseline (T-score < -2.5)
结局指标
主要结局
Bone mineral density, bone mineral content and bone geometry measured by DEXA. Vascular elasticity, intima-media thickness and pulse wave velocity measured by ultrasound
时间窗: three years
次要结局
- The vitamin K-dependent proteins: uncarboxylated osteocalcin (ucOC), carboxylated osteocalcin (cOC), uncarboxylated matrix-Gla protein (ucMGP) and carboxylated matrix-Gla protein cMGP)(three years)