Bone Mineral Density (BMD) Changes in a Bone Health Plan Using Two Versions of a Bone Health Supplement: A Comparative Effectiveness Research (CER) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 354
- 试验地点
- 2
- 主要终点
- Changes in Bone Mineral Density (BMD)
研究概览
简要总结
A comparison of changes in bone density following the same bone-health plan, but with a different bone-health supplement.
详细描述
The US Surgeon General's Report on Bone Health suggests America's bone-health is in jeopardy and issued a "call to action" to develop bone-health plans that:
- improve nutrition,
- increase health literacy and,
- increase physical activity.
The purpose of this study was to use a comparative effective research model to compare 6-month changes in bone mineral density (BMD)in two study groups. Both followed the same bone health plan that contained the three components listed above with the same plant-source calcium supplement, but enhanced with different levels of calcium, vitamin D3, vitamin K and magnesium.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects were required to contact the physicians to ensure they had no medical issues that would preclude their participation.
排除标准
- •Younger the 18 years of age, and
- •Recommendations not to participate from their physicians.
结局指标
主要结局
Changes in Bone Mineral Density (BMD)
时间窗: baseline and 6 months
Measurements of bone mineral density were conducted at baseline and 6 months from baseline in two different study groups following the same bone-health behavior modification plan, but with different versions of a bone-health calcium supplement.
次要结局
- A comparison of changes from baseline in 43-blood chemistry panel and a self-reported quality of life inventory in both study groups(six months)