Oral Vitamin D Supplementation in Elderly Women: Twice a Day or Three Times a Year? A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Blood 25 OH D vitamin concentrations
研究概览
简要总结
The aim of this study is to compare oral vitamin D supplementation administered in two different ways, namely either twice a day (800IU/d, 292000IU/y) or three times a year (97333IU every 4 months, 292000IU/y) in elderly women in combination with daily supplementation of calcium 1 gram. We will 1)compare the blood concentrations of 25 OH vitamin D in the two treatment groups amd monitor if a sufficient and safe concentration of 25OH D in blood can be maintained with these two treatments.2) Find out seasonal variation in vitamin D concentrations in these treatments. 3) Find out safety of these treatments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 70 Years 至 80 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •70-80 years
- •Living in the community
排除标准
- •Renal disease
- •Diseases that contraindicate vitamin D supplementation
- •Medications affecting bone
- •Malignancy
研究组 & 干预措施
1
干预措施: vitamin D twice daily (Dietary Supplement)
2
干预措施: Vitamin D3 oil three times in a year (Dietary Supplement)
结局指标
主要结局
Blood 25 OH D vitamin concentrations
时间窗: 8 times during the year
次要结局
- serum calcium, 24-hour calcium excretion in urine, creatinine clearance(8 times during the year)