Effective Prevention of Osteoporosis Through Rehabilitation and Training
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Bone Mineral Density
研究概览
简要总结
The study involves 120 women over the age of 50.
All participants in the study take part in high-intensity strength training for 10 months.
In addition, half of the participants receive vitamin D3 at a dose of 4,000 IU/day.
The investigators hypothesize that training combined with vitamin D3 supplementation will be more effective in preventing osteoporosis than training alone.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age over 50
排除标准
- •ongoing cancer,
- •unstabilized cardiovascular disease,
- •cognitive disorders,
- •radiological treatment in the last 12 months,
- •other contraindications to undertaking high-intensity strength training,
- •diseases affecting the skeleton such as: Paget's disease, type I diabetes mellitus,
- •taking medications affecting skeletal conditions including: long-term therapy with corticosteroids, thiazides, antiretroviral drugs,
- •contraindications to taking vitamin D including: hypercalcemia, nephrolithiasis, sarcoidosis, lack of cholecalciferol hydroxylase activity in the liver and kidneys.
研究组 & 干预措施
Vitamin D3 supplementation
Group receiving vitamin D3 at a dose of 4000 IU / day
干预措施: Supplementation of vitamin D3 (Dietary Supplement)
Placebo supplementation
Vegetable oil as a placebo.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Bone Mineral Density
时间窗: Measured at 3 time points: before the experiment, after 10 months of training, and at 6 months after the end of training and supplementation.
Test to determine bone mineral density by densitometry.
次要结局
- Vitamin D metabolites level(Measured at 4 time points: before the experiment, after 5 and 10 months of training, and at 6 months after the end of training and supplementation.)
研究者
Mateusz Karnia
Principal Investigator
University of Gdansk