Assessing the Efficacy of Melatonin and Osteogenic Loading on Bone Health in an Osteopenic Population: MelaOstrong Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Bone mineral density
研究概览
简要总结
This study will be assessing the efficacy of melatonin and/or osteogenic loading on modulating bone health in an osteopenic population.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo/Mock
Placebo capsules; mock osteogenic loading
干预措施: Mock for Osteogenic Loading (Device)
Placebo/Mock
Placebo capsules; mock osteogenic loading
干预措施: Placebo (plant fiber) for melatonin (Drug)
Melatonin/Mock
Melatonin capsules; mock osteogenic loading
干预措施: Melatonin 5 mg (Drug)
Melatonin/Mock
Melatonin capsules; mock osteogenic loading
干预措施: Mock for Osteogenic Loading (Device)
Placebo/Osteogenic loading
Placebo capsules/osteogenic loading
干预措施: Osteogenic loading (Device)
Placebo/Osteogenic loading
Placebo capsules/osteogenic loading
干预措施: Placebo (plant fiber) for melatonin (Drug)
Melatonin/Osteogenic loading
Melatonin capsules/osteogenic loading
干预措施: Melatonin 5 mg (Drug)
Melatonin/Osteogenic loading
Melatonin capsules/osteogenic loading
干预措施: Osteogenic loading (Device)
结局指标
主要结局
Bone mineral density
时间窗: O-12 months
Bone mineral density (BMD) at baseline (month 0) and month 12. Bone density will be assessed by dual energy x-ray absorptiometry (DXA) scan at baseline (month 0) and at month 12. Bone density, expressed as percentage change from baseline (T-scores), will be compared within and between groups at 12 mos.
次要结局
未报告次要终点