Phase II Study of Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause: a Randomised Double Blind Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 4
- 主要终点
- Bone mass density
研究概览
简要总结
Study Objective: To determine whether Natto supplementation in women immediately after menopause might prevent severe bone loss
Study population: Women 50 - 60 years, 1-5 years after menopause
Study Design: Double-blind, placebo-controlled, randomized controlled trial. A "phase II" clinical trial.
Instruments Used to Measure Therapeutic Response: Lunar Prodigy DEXA bone densitometer
Study Treatment Group: Daily supplementation with Vitamin K2, "NATTO"
Study Control Group: Identically-looking placebo medication
Duration of treatment: 12 months
Duration of Subject Participation in Study: 12 months Assessment of Therapeutic response: Given an expected reduction of bone mass density of - 1.1% annually in the placebo group, the minimum clinically significant difference between the groups is 0.3 percentage points. The trial is therefore powered to detect a reduction in annual bone mass loss of 0.3 percentage points in the treatment group.
Numbers of Evaluable Subjects Required: 304 Maximum # Subjects 334
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women living in the city of Tromsø, not using hormone replacement therapy, 1-5 years after menopause.
排除标准
- •History of hip fracture
- •Bone disease affecting bone mineral density
- •Use of vitamin K antagonists
- •Significant co-morbidity that makes it difficult to obtain BMD measurements
- •Use of hormone replacement therapy or other therapy that influence bone remodeling
结局指标
主要结局
Bone mass density
次要结局
未报告次要终点